ABCDEFGHIJKLMNOPQRSTUVW
1
Sr. NoNotified onGeneric nameBrand nameRelevant batch number/s ManufacturerLocal agentRegistration statusDefectRegulatory action
Recall/Revoke Notification letter
Remarks
2
103.01.2020Warfarin Tablets BP 5mgNATW-020005Centurion remedies Pvt Ltd, G/5 and G/6, Industrial Estate Gorwa, Vadodara-390016, Gujarat, IndiaYaden InternationalRegisteredtablets are easily broken in to pieces while removing from the blistersWithhold the batch
NMRA/CP/P32/QF01/2020
NA
3
214.01.2020Warfarin Tablets BP 5mgNATW-020005Centurion remedies Pvt Ltd, G/5 and G/6, Industrial Estate Gorwa, Vadodara-390016, Gujarat, IndiaYaden internationalRegisteredtablets are easily broken in to pieces while removing from the blisterswithdraw the batch
NMRA/CP/P32/QF01/2020
NA
4
329.01.2020Warfarin Tablets BP 5mgNANACenturion remedies Pvt Ltd, G/5 and G/6, Industrial Estate Gorwa, Vadodara-390016, Gujarat, IndiaYaden InternationalRegisteredeasily breakable while removing the primary pack.INR value could not be monitored in the patientsWithdraw the product
NMRA/CP/P32/QF01/2020
The decision was revoked by the MEC held on 15th Dec 2020.
5
407.02.2020Co-Careldopa Tablets BP 250/25mgNATC-1030001Centurion remedies Pvt Ltd, G/5 and G/6, Industrial Estate Gorwa, Vadodara-390016, Gujarat, IndiaYaden internationalRegisteredpresence of brown/black sports on surface of tablets in intact containerwithhold the batch
NMRA/CP/P32/QF02/2020
NA
6
507.02.2020Vancomycin hydrochloride for Injection USP 500 mgNASX-19030Swiss Parenterals Pvt Ltd, 809, Kerala, GIDC, Nr.Bavla, Gujarat, IndiaPTC Medical Pvt LtdRegistered(1) failure to comply with USP specification with respect to the uniformity of dosage unit (2) Some vials had parts of another label in addition to the label of the primary pack.withdraw the batch
NMRA/CP/P32/QF03/2020
NA
7
613.02.2020Omeprazole for injection 40mgNAADE-065not mentionedSiba Holdingsregistered Manufacturer's name and address is not indicated on the label.Withdraw the batch
NMRA/CP/P32/QF04/2020
NA
8
726.02.2020Irinotecan hydrochloride trihydrate Injection USP 1000 mg/5mlIrinotin 100DH-I1-9Belco Pharma,515,MIE, Bahadurgarh, Hariyana, IndiaPharmatec (Pvt ) LtdRegisteredfailure to comply with particulate matter testWithhold the batch
NMRA/CP/P32/QF05/2020
NA
9
826.02.2020Cyclosporine Capsules USP 50mgHumaine 50C19G002Olive Healthcare, 197/2, Athiyawad, Dabhel Village, Daman-396210, (U.T), IndiaSlim PharmaceuticalsRegisteredfailure due to melted capsules in the intact blister packWithhold the batch
NMRA/CP/P32/QF06/2020
NA
10
926.02.2020Paracetamol Tablets BP 500mgMcmol 500MP8549McCoy Pharma Pvt Ltd, S-12, MIDC, Tarapur, Dist.palghar, Maharashtra 401506, IndiaPharmatec (Pvt ) LtdRegisteredsample is unsatisfactory due to black patches in almost all tablets in the sealed pack submitted by the source.Withhold the batch
NMRA/CP/P32/QF07/2020
NA
11
1026.02.2020Cephalexin for Oral Suspension USP 125 mg/5mlNA47A802Interpharm Pvt Ltd, Sri LankaNARegisteredsample is unsatisfactory due to observation of orange coloured clumps in the content of some intact bottles.Withhold the batch
NMRA/CP/P32/QF08/2020
NA
12
1110.03.2020Calcium Gluconate Injection BP 1g/10mlNA170843Hebei Tiancheng Pharmaceutical Co Ltd, No 18, Jinguang Street, Economic and Technological Development Zone, Cangzhou City, Hebei Province, ChinaSlim PharmaceuticalsRegisteredSample does not confirm to BP specification with respect to labelling requirementWithhold the batch
NMRA/CP/P32/QF09/2020
NA
13
1217.03.2020Rub-in Hand DisinfectantSterimedSM01A20Medicom , 60/1, park Street, Colombo 02NARegisteredsample is considered unsatisfactory due to dead cockroach was observed in one bottle received to the NMQAL and pump bottles are not tamper evident.plastic wrapper seal is only limited to the cap with squeezing tipWithdraw the batch
NMRA/CP/P32/QF10/2020
NA
14
1317.03.2020Bisoprolol Fumarate Tablets USP 5mgBristol 5FG9016Fredun Pharmaceuticals, IndiaGeorge SteuartRegisteredSample is unsatisfactory as some boxes/sealed packs contain less number of tablets than stated on the label of the outer carton.withdraw the batches
NMRA/CP/P32/QF19/2017
NA
15
1403.06.2020Ampicillin for Injection BP 1000mgAmpicil 1000031118AMP3Navesta Pharmaceuticals Pvt Ltd, 107A, Nakandala Road, Kindelpitiya, Millewa, Horana, Sri LankaNARegisteredSample does not conform to BP Specification with respect to the water testwithhold the batch
NMRA/CP/P32/QF11/2020
NA
16
1522.06.2020Penicillin G Benzathine for injection 1.2MIUBenzid 1.2010818PGB1 020818PGB1 030818PGB1 010119PGB1Navesta Pharmaceuticals Pvt Ltd, 107A, Nakandala Road, Kindelpitiya, Millewa, Horana, Sri LankaNARegisteredsample does not conform to manufacturer's specification with respect to the water contentwithdraw the batches
NMRA/CP/P32/QF12/2020
NA
17
1623.06.2020Labetalol Hydrochloride Injection USP 100mg/20mlLabeverE2221901Verve Human care Laboratories, IndiaLeader Pharma Pvt LtdRegisteredsample does not conform to USP specification with respect to the particulate matter test.Withdraw the batch
NMRA/CP/P32/QF14/2020
NA
18
1724.06.2020Flumazenil Injection USP 500mcg/5mlNANAMercury Laboratories Ltd, IndiaYaden InternationalRegisteredLabelling (batch number allocated to the product was wrong)Voluntary Recall
NMRA/CP/P32/VR02-I/2020
NA
19
1826.06.2020Dextrose Injection USP 50%w/vNA19363313Mercury Laboratories Ltd, 2/13-14, Gorwa Industrial Estate, Gorwa, Vadodara-390016, Gujarat, IndiaYaden internationalregisteredsample is considered unsatisfactory due to brown stains in an intact vialwithdraw the batch
NMRA/CP/P32/QF13/2020
NA
20
1902.07.2020Multivitamin and Mineral DropsZincovit DropsZDDE19004Apex LaboratoriesA.Baur & Co Pvt LtdregisteredDetection of black particles inside the bottles of Zincovit D dropsVoluntary Recall
NMRA/CP/P32/VR/02-II/2020
NA
21
2008.07.2020Meropenem for Injection USP 1000 mgNA0329Z011Scott-Edil Advance Research Laboratories & Education Ltd, Hilltop Ind Area, Bhatoli Kalan, Baddi, Distt.Solan 173205, Himachal Pradesh, IndiaPTC Medical Pvt LtdRegistered01) Color variation from white to off white/yellow/brown in the intact vial and reconstituted solution. 02) Content of some vial were stuck to the bottom of the vial 03) clump formation in some vials 04) assay does not conform to USP specificationWithdraw the batch
NMRA/CP/P32/QF06/2019
NA
22
2110.07.2020Meropenem for Injection USP 500 mgMeropenem 500IC18264011inject Care Parenterals Pvt Ltd, Plot No 130, Silvassa Road, GIDC, Vapi 396195, IndiaYaden International Pvt Ltdregisteredsample is unsatisfactory due to 01) Powder in some vials are not free flowing 02) Colour variation (off white to pale yellow) was observed among the contents of the vials received at the NMQALWithhold the batch
NMRA/CP/P32/QF23/2019
NA
23
2216.07.2020Desmopressin Nasal Spray 0.1mg/mlMinirinall batchesFerring GmbH, Wittland 11, 24109, Kiel, GermanySunshine Healthcare Lanka LtdRegisteredNasal Spray bottle containing low volume have been observed and out of specification results for both active substance, desmopressin and Excipient, benzalkonium Chloride contents have been measured.Voluntary Recall
NMRA/CP/P32/VR03/2020
NA
24
2322.07.2020Meropenem for Injection USP 1000 mgNA0328Z006Scott-Edil Advance Research Laboratories & Education Ltd, Hilltop Ind Area, Bhatoli Kalan, Baddi, Distt.Solan 173205, Himachal Pradesh, IndiaPTC Medical Pvt LtdRegistered01) NMQAL observed different colours of powder in different intact vials of the same batch. (02) Content of some vial were stuck to the bottom of the vialWithhold the batch
NMRA/CP/P32/QF06/2019
NA
25
2422.07.2020Levothyroxine Sodium Tablets USP 100mcgThyromega 100T2779014The ACME Laboratories Ltd, Dhaka, BangladeshMega Pharma Pvt LtdRegisteredSample does not conform to USP specification with respect to uniformity of dosage unit and assayWithhold the batch
NMRA/CP/P32/QF15/2020
NA
26
2507.08.2020Amoxicillin and Clavulanate Potassium Tablets USP 375 mgAvam 375T17IAB03AMN Life Science Pvt Ltd, 150, Sahajanand Estate, Sarkhej, Tal City. Ahmedabad, Gujarat State, Indiapharma AssociatesRegisteredSample is considered unsatisfactory due to following reason: all intact blisters in the aluminium blister packs are swollen and deformed.Withhold the batch
NMRA/CP/P32/QF16/2020
NA
27
2611.08.2020Ipratropium bromide dry powder capsules 40mcgIpravent DP capsGD91484Cipla Ltd, L-139 o L-146, Verna Industrial Estate, Verna, Goa, IndiaBreathfree Lanka Pvt LtdregisteredDeposition of Emitted dose in the stability sample does not comply with the specificationwithhold the batch
NMRA/CP/P32/QF17/2020
NA
28
2721.08.2020Meropenem for Injection USP 1000 mgNANAScott-Edil Advance Research Laboratories & Education Ltd, Hilltop Ind Area, Bhatoli Kalan, Baddi, Distt.Solan 173205, Himachal Pradesh, IndiaPTC Medical Pvt LtdRegisteredsample is unsatisfactory due to 01) Color variation from white to dark brown color of powder was observed in some intact vials received at NMQAL. 02) failure to comply with assay test 03) failure to comply with constituted solution testWithdraw the product
NMRA/CP/P32/QF06/2019
NA
29
2826.08.2020Meropenem for Injection USP 500 mgNAAA4536PT Sambe Farma, JI.Mahar Martanegara No.162 (JI.Leuwigajah No.162), RT.12, Kel.Baros, Kec.Cimahi Tengah, Cimahi, IndonesiaLifeline PharmaceuticalsRegisteredSample unsatisfactory due to presence of a piece of glass in a reconstituted vial submitted by the source.Withdraw the batch
NMRA/CP/P32/QF18/2020
NA
30
2926.08.2020Amoxicillin Capsules USP 500 mgTheomox-500EBC 190048Theon Pharmaceuticals Ltd, Vill.Saini Majra, Tehsil Nalagarh, Dist.Solan (HP)-174101, IndiaSlim PharmaceuticalsRegisteredSample does not conform to USP specification with respect to the dissolution testWithhold the batch (EBC 190048)
NMRA/CP/P32/QF33/2017
NA
31
3026.08.2020Pyridostigmine Tablets BP 60mgNAP-68004Centurion Laboratories Pvt Ltd, Plot No.P-2, Savli Biotech Parek, At.Manjusar, Tal.Savli, Dist.Vadodara, IndiaYaden InternationalRegisteredCapping and chipping of tablets in intact srtip packsWithhold the batch
NMRA/CP/P32/QF19/2020
NA
32
3108.09.2020Lithium Carbonate Tablets USP 250 mgNASR43703, SR43702Atoz Pharmaceuticals Pvt Ltd, 12, Balaji Nagar. Ambattur, Chennai-600053, IndiaEuro Asian Pharma Pvt Ltdregistered01) sample does not conform to USP specifications with respect to Assay. 02) NMQAL observed that tablets split and disintegrate when the seal of bags are open and exposed to environmentWithdraw the batches
NMRA/CP/P32/QF10/2019
NA
33
3206.10.2020Flucloxacillin Capsules BP 500mgFlucillin 500NATheon Pharmaceuticals Ltd, Vill.Saini Majra, Tehsil Nalagarh, Dist.Solan (HP)-174101, IndiaSlim Pharmaceuticalsregistered(01) sample does not conform to BP specifications with respect to the related substances test. (02) sample is unsatisfactory due to swollen blisters and broken seal.withhold the product
NMRA/CP/P32/QF20/2020
NA
34
3306.10.2020Dexamethasone Tablets BP 4mgN/ATE 4928Bafna Pharmaceuticals Ltd, No.13, Sundara Vinayagar Koil Street, Madhvaram, Chennai-600060,Indiapharma Associatesregistered Sample is unsatisfactory as brown patches were observed on some of the tablets in intact containers.withdraw the batch
NMRA/CP/P32/QF21/2020
NA
35
3408.10.2020Flucloxacillin Capsules BP 500mgFlucillin 500NATheon Pharmaceuticals Ltd, Vill.Saini Majra, Tehsil Nalagarh, Dist.Solan (HP)-174101, IndiaSlim Pharmaceuticalsregistered sample is unsatisfactory due to swollen blisters and broken seal.withdraw the product
NMRA/CP/P32/QF20/2020
NA
36
3509.10.2020Flucloxacillin Capsules BP 250mgFlucillin 250EBC190063Theon Pharmaceuticals Ltd, Vill.Saini Majra, Tehsil Nalagarh, Dist.Solan (HP)-174101, IndiaSlim Pharmaceuticalsregistered sample is unsatisfactory due to swollen blisters and broken seal.withhold the batch
NMRA/CP/P32/QF22/2020
NA
37
3615.10.2020Metoprolol Tartrate Tablets BP 50mgNA(TM-190001)Centurion remedies Pvt Ltd, G/5 and G/6, Industrial Estate Gorwa, Vadodara-390016, Gujarat, IndiaYaden Internationalregistered sample is unsatisfactory due to some tablets break in to pieces when taking out of the blister packWithhold the batch
NMRA/CP/P32/QF23/2020
NA
38
3715.10.2020Cefuroxime for Injection USP 250 mgZAFUROX29ZAFA Pharmaceutical Laboratories Pvt Ltd, Plot No.B-10, Block-B, S.I.T.E, North Karachi, Karachi, PakistanYaden Internationalregisteredsample does not confirm to USP specifications with respect to uniformity of dosage unit and assayWithholding the batch
NMRA/CP/P32/QF36/2018
NA
39
3815.10.2020Amoxicillin and Potassium Clavulanate for Oral Suspension USP 156/5mlIndclave 156(D0569008SR)Indchemie Health Specialities Pvt Ltd, Village-Thane, Tehsil-Baddi, Dist.Solan, Himachal Pradesh-173205, Indiapharma AssociatesRegisteredsample is considered unsatisfactory due to the colour variation of the context among the intact bottle after reconstitution.Withdraw the batch
NMRA/CP/P32/QF11/2018
NA
40
3920.10.2020Dextrose Injection USP 50%w/vNA20363312Mercury Laboratories Ltd, 2/13-14, Gorwa Industrial Estate, Gorwa, Vododara-390016, Gujarat, IndiaYaden InternationalregisteredSample does not conform to USP specification with respect to the visible particulates in injectionwithdraw the batch
NMRA/CP/P32/QF13/2020
NA
41
4020.10.2020Disulfiram Tablets BP 250mgNA20195901Mercury Laboratories Ltd, Unit No.02, Halol Baroda Road, Village:Jarod, Ta: waghodia, Dist : Vadodara-391510, IndiaYaden Internationalregisteredsample is considered unsatisfactory due to mottled appearance of tablets in intact containerWithhold the batch
NMRA/CP/P32/QF24/2020
NA
42
4123.10.2020Flucloxacillin Powder for Suspension BP 125mg/5mlFlubioticNANavana Pharmaceuticals Ltd, Rupshi, Narayanganj, bangladeshDarly butler Co Ltdregisteredsample does not conform to BP specification with respect to the acidity testwithdraw the product
NMRA/CP/P32/QF25/2020
NA
43
4227.10.2020Chlorpheniramine Tablets BP 4mgNATE 4987, TE-4990Bafna Pharmaceuticals Ltd, No.13, Sundara Vinayagar Koil Street, Madhvaram, Chennai-600060,Indiapharma AssociatesregisteredSample does not conform to BP specification with respect to Uniformity of weightwithdraw batches
NMRA/CP/P32/QF26/2020
NA
44
4328.10.2020Chlorpheniramine Tablets BP 4mgNANABafna Pharmaceuticals Ltd, No.13, Sundara Vinayagar Koil Street, Madhvaram, Chennai-600060,Indiapharma Associatesregisteredsample does not conform to BP specification with respect to Assay and Uniformity of weightwithdraw the product
NMRA/CP/P32/QF26/2020
NA
45
4404.11.2020Cloxacillin for Injection 250mgClomax 250140618CLX1Navesta Pharmaceuticals Pvt Ltd, 107A, Nakandala Road, Kindelpitiya, Millewa, Horana, Sri LankaRegisteredSample does not conform to BP specification with respect to the water testRevoke product withhold decision and withdraw one batch
NMRA/CP/P32/QF19/2019
NA
46
4511.11.2020Pyridostigmine Bromide Tablets BP 60mgNAP-68004Centurion Laboratories Pvt Ltd, Plot No.P-2, Savli Biotech Parek, At.Manjusar, Tal.Savli, Dist.Vadodara, IndiaYaden InternationalRegisteredCapping and chipping of tablets in intact srtip packsWithdraw the batch
NMRA/CP/P32/QF19/2020
NA
47
4611.11.2020Hydralazine Hydrochloride injection USP 20 mg/mlNA9EB18367Ciron drugs and Pharmaceuticals Pvt Ltd, N-118/119, 113, 119/1, 119/2, 118/1, M.I.D.C, Tarapur, Boisar, Dist.Palghar 401506, IndiaCeyoka Pvt Ltdregisteredsample is unsatisfactory as large number of suspended particle were observed in almost all the vials submitted at NMQALwithdraw batch
NMRA/CP/P32/QF27/2020
NA
48
4711.11.2020Furosemide Inj BP 10mg/mlNA20F01Pharmafabrikon, Unit II, 91-1, Sivagangai Road, Vilathur, Maduari 625020, IndiaNovachem Lanka Pvt Ltdregisteredsample does not conform to BP specifications with respect to Assay testwithhold the batch
NMRA/CP/P32/QF28/2020
NA
49
4811.11.2020Amlodipine Besylate Tablets USP 2.5mgNA19181603Mercury Laboratories Ltd, Unit No 02, Halol Baroda, Village: Jarod, Ta: Waghodia, Dist: Vadodara-391510, IndiaYaden Internationalregisteredsample is not satisfactory due to presence of brown/yellow patches and broken edges of some tablets in intact containerwithhold the batch
NMRA/CP/P32/QF29/2020
NA
50
4920.11.2020Metoprolol Tartrate Tablets BP 50mgNA(TM-190024)Centurion remedies Pvt Ltd, G/5 and G/6, Industrial Estate Gorwa, Vadodara-390016, Gujarat, IndiaYaden Internationalregistered sample does not conform to BP specifications with respect to Assay testWithhold the batch
NMRA/CP/P32/QF23/2020
NA
51
5027.11.2020Phytomenadione Inj BP 1mg/0.5mlVitamin K1CA 19005Steril-Gane Life Sciences (P) Ltd, No.45, Mangalam Village, Villianur Commune, Puducherry-605110, Indiapharma AssociatesregisteredSample does not conform to BP specifications with respect to the test for Extractable volumeWithdraw the batch
NMRA/CP/P32/QF30/2020
NA
52
5127.11.2020Chondroithin sulphate sodium 4%w/v and sodium hyaluronate 3% w/v Ophthalmic SolutionHyvet-CHYB-002Sunways Rohto Pharmaceutical Pvt Ltd, 803/4/5, GIDC, Dholka, Ahmedabad-382225, Indiayaden Internationalregisteredsample is unsatisfactory due to the name and address of the manufacturer is not indicated on the label.withdraw batch
NMRA/CP/P32/QF31/2020
NA
53
5227.11.2020PEG+ Electrolytes Powder for Oral Solution 69gklean Prep38003582Helsinn Birex Pharmaceuticals Ltd, Damastown, Mulhuddrt, Dublin 15, IrelandHemas Pharmaceutical Pvt LtdregisteredColour variation among powders in sachets and the reconstituted solutionwithhold batch
NMRA/CP/P32/QF32/2020
NA
54
5327.11.2020Calamine BP (Fine Powder) 500gNACA-001Neelkanth Minechem, IndiaUnregisteredlabelling defect. Wrong instruction about storagewithhold batch
NMRA/CP/P32/QF33/2020
NA
55
5427.11.2020Bupivacaine HCl in Dextrose Inj USP 5mg/80mgNA0EB03120 0EB01110Ciron drugs and pharmaceuticals Pvt Ltd,N-118, 119, 113, 119/1, 119/2 & 118/1, MIDC, Tarapur, Boisar, Dist.Palghar-401506, IndiaCeyoka Pvt LtdregisteredSample does not conform to USP specification with respect to the Assay for Dextrosewithhold batches
NMRA/CP/P32/QF34/2020
Revoke the batch withheld decision on 23..08.2021 based on NMQAL recommendation
56
5504.12.2020Bupivacaine HCl in Dextrose Inj USP 5mg/80mgNA0EB02119Ciron drugs and pharmaceuticals Pvt Ltd,N-118, 119, 113, 119/1, 119/2 & 118/1, MIDC, Tarapur, Boisar, Dist.Palghar-401506, IndiaCeyoka Pvt LtdregisteredSample does not conform to USP specification with respect to the Assay for Dextrosewithhold batches
NMRA/CP/P32/QF34/2020
Revoke the batch withheld decision on 23..08.2021 based on NMQAL recommendation
57
5623.12.2020PEG+ Electrolytes Powder for Oral Solution 69gklean Prep38003581 38002638Helsinn Birex Pharmaceuticals Ltd, Damastown, Mulhuddrt, Dublin 15, IrelandHemas Pharmaceutical Pvt LtdregisteredColour variation among powders in sachets and the reconstituted solutionwithhold batch
NMRA/CP/P32/QF32/2020
NA
58
5724.12.2020Vancomycin hydrochloride for Injection USP 1gNAXD0A005Scott-Edil Pharmacia Ltd, 56, E.P.I.P, Phase I, Jharmajri, Baddi-173205, Dist.Salon, Himachal Pradesh, IndiaPTC Medical Pvt LtdRegisteredSample does not conform to USP specifications with respect to completeness and clarity of solution ( Particles were observed in the reconstituted solutions of some vials)Withdraw the batch
NMRA/CP/P32/QF35/2020
NA
59
5804.01.2021Ciprofloxacin Eye/Ear DropsCiproconD20C14Indiana Ophthalmics, 135,136,137, GIDC Estate, Wadhwan City-363035, Gujarat, IndiaChamee ChemistRegisteredsample does not conform to manufacturers specification with respect to the description of the product.Withdraw the batch
NMRA/CP/P32/QF01/2021
NA
60
5904.01.2021Levothyroxine Sodium Tablets USP 100mcgThyromega 100T2779007The ACME Laboratories Ltd, Dhaka, BangladeshMega Pharma Pvt LtdRegisteredsample does not confirm to specification with respect to Uniformity of dosage unit.Withhold the batch
NMRA/CP/P32/QF15/2020
NA
61
6015.01.2021Doxycycline Hyclate Capsules USP 100mgNA141ZAFA Pharmaceutical Laboratories (Private) Ltd, L-1/B, Block-22, Federal 'B', Industrial Area, Karachi-75950, pakistanYaden International Pvt Ltdregisteredsample is considered unsatisfactory due to the presence of yellow colour dust within intact blistersWithhold the batch
NMRA/CP/P32/QF02/2021
NA
62
6126.01.2021Disulfiram Tablets BP 250mgNA20195901Mercury Laboratories Ltd, Unit No.02, Halol Baroda Road, Village:Jarod, Ta: waghodia, Dist : Vadodara-391510, IndiaYaden Internationalregistered sample is considered unsatisfactory due to mottled appearance of tablets in intact containerWithdraw the batch
NMRA/CP/P32/QF24/2020
manufacturer accepted the failure and suggested corrective and preventive actions.
63
6226.01.2021Amylodipine Besylate Tablets USP 2.5 mgNA19181603Mercury Laboratories Ltd, Unit No 02, Halol Baroda, Village: Jarod, Ta: Waghodia, Dist: Vadodara-391510, IndiaYaden International RegisteredSample was not satisfactory due to presence of brown /yellow patches and broken edges of some tablets in intact container.Withdraw the batch
NMRA/CP/P32/QF29/2020
NA
64
6312.03.2021Gastro Resistant Sodium Valproate Tablets BP 200mgNAT20F233Pharmafabrikon, Unit II, 91-1, Sivagangai Road, Vilathur, Maduari 625020, IndiaNovachem Lanka Pvt Ltdregisteredsample is unsatisfactory due to presence of melted tablets in intact metal stripwithhold the batch
NMRA/CP/P32/QF03/2021
NA
65
6416.03.2021Deferoxamine Mesilate for Injection USP 500 mgDemoferidon1705777Demo S.A.Pharmaceuticals Industry, 21st Km, National Rd, Athens-Lamia. Krioneri, GreeceAccess International Pvt LtdRegisteredsample does not conform to USP specification with respect to the water determinationwithhold the batch
NMRA/CP/P32/QF21/2018
NA
66
6529.03.2021Cefuroxime for injection USP 250 mgZAFUROX30ZAFA Pharmaceutical Laboratories Pvt Ltd, Plot No.B-10, Block-B, S.I.T.E, North Karachi, Karachi, PakistanYaden InternationalRegisteredsample does not conform to USP specification with respect to the water determinationwithhold the product
NMRA/CP/P32/QF36/2018
NA
67
6631.03.2021Manitol Injection IP 20% w/vNA19PMN017Pentagon Labs Limited, 16C/16D, Industrial area No 1, AB Road, Dewas 455001 (MP), India for Bureau of Pharma PSU of India IDPL Plant Complex, Dundahera Gurgaon 122016, Hyryana-Unregisteredsample is considered unsatisfactory due to presence of black floating particle in an intact container and due to poor container design.withdraw the batch
NMRA/CP/P32/QF04/2021
NA
68
6731.03.2021Metaraminol Injection BP 10mg/mlNA20368402Mercury Laboratories Ltd, Unit No.1,2/13-14, Gorwa Industrial Estate, Gorwa, Vadodara-390016, Gujarat, IndiaYaden InternationalRegisteredsample does not conform to BP specifications with respect to extractable volume.NMQAL observed that one ampoule was almost emptywithdraw the batch
NMRA/CP/P32/QF05/2021
NA
69
6809.04.2021Co-Careldopa Tablets BP 250/25mgNATC-1030001Centurion remedies Pvt Ltd, G/5 and G/6, Industrial Estate Gorwa, Vadodara-390016, Gujarat, IndiayadenRegisteredpresence of brown/black sports on surface of tablets in intact containerwithdraw the batch
NMRA/CP/P32/QF02/2020
manufacturer explanation has not been submitted
70
6919.04.2021Doxycycline Hyclate Capsules USP 100mgNA141ZAFA Pharmaceutical Laboratories (Private) Ltd, L-1/B, Block-22, Federal 'B', Industrial Area, Karachi-75950, pakistanYaden International Pvt Ltdregisteredsample is considered unsatisfactory due to the presence of yellow colour dust within intact blistersWithdraw the batch
NMRA/CP/P32/QF02/2021
manufacturer explanation has not been submitted
71
7022.04.2021PEG+ Electrolytes Powder for Oral Solution 69gklean Prep38003582Helsinn Birex Pharmaceuticals Ltd, Damastown, Mulhuddrt, Dublin 15, IrelandHemas Pharmaceutical Pvt LtdregisteredColour variation among powders in sachets and the reconstituted solutionwithdraw the batch
NMRA/CP/P32/QF32/2020
manufacturer explanation has not been submitted
72
7128.04.2021PEG+ Electrolytes Powder for Oral Solution 69gklean Prep38002638 38003581Helsinn Birex Pharmaceuticals Ltd, Damastown, Mulhuddrt, Dublin 15, IrelandHemas Pharmaceutical Pvt LtdregisteredColour variation among powders in sachets and the reconstituted solutionwithdraw the batches
NMRA/CP/P32/QF32/2020
manufacturer explanation has not been submitted
73
7228.04.2021Paracetamol Tablets BP 500mgNADPTE01State Pharmaceutical Manufacturing Corporation, RathmalanaNARegisteredSample is considered unsatisfactory due to presence of brown patches on the surface of some tablets in intact packsWithhold the batch
NMRA/CP/P32/QF17/2019
NA
74
7304.05.2021Metformin Tablets BP 500mgNAH1181Fourrts (India) Laboratories Pvt Ltd, Vandalur Rd, Kelambakkam-603103, Tamil Nadu, IndiaSunshine Healthcare Lanka LtdRegisteredsample does not conform BP specification for the test for uniformity of weightWithdraw the batch
NMRA/CP/P32/QF06/2021
NA
75
7406.05.2021Gastro Resiatant Sodium Valproate Tablets BP 200mgNAS-11031Mercury Laboratories Ltd, Unit No.02, Halol Baroda Road, Village:Jarod, Ta: waghodia, Dist : Vadodara-391510, IndiaYaden InternationalRegisteredSome tablets are melted in sealed metal stripDiscontinue to use the packs which show the defect
NMRA/CP/P32/QF07/2021
NA
76
7511.05.2021Meropenem for injection USP 500mgNAP50906Sanjivani Parenteral limited, R-40, TTCIndl.Area, Rabale, Thane-Belapur Road, Navi Mumbai 400701, IndiaCanoe Medicare Pvt LtdRegisteredSample does not confirm to USP specifications with respect to the test for uniformity of dosage units and assaywithhold the batch
NMRA/CP/P32/QF08/2021
NA
77
7611.05.2021Flucloxacillin Oral suspension BP 125mg/5mlFloclox Powder for oral suspensionTK066 and KE001Advanced Chemical Industries Limited, 7, Hajeegonj Road, gonnyl Narayangonj, BangladeshCIC Holdings PLCregisteredsample does not conform to the BP specification with respect to the definision.withdraw batches
NMRA/CP/P32/QF09/2021
NA
78
7719.05.2021Cyclophosphamide tablets BP 50mgN/AAT-010221BDH Industries Ltd, Nair Baug.Akurli Road, Kandivli (East),Mumbai 400101, IndiaRavilux Company (Pvt) Ltdregisteredsample is unsatisfactory due to presence of brown patches on the tablets in the intact containerWithhold batch
NMRA/CP/P32/QF10/2021
NA
79
7820.05.2021Irinotecan hydrochloride trihydrate Injection USP 40mg/2mlIrinotin-40 injection 2ml vialD-I2-9Belco Pharma, 515, MIE, Bahadurgarh-124507 (Haryana), IndiaPharmatec Private Limitedregisteredsample is unsatisfactory due to presence of particles in intact vials and turbidity appearance in contentWithdraw the batch
NMRA/CP/P32/QF11/2021
NA
80
7902.06.2021Amitriptyline Hcl tablets USP 10mgNAH20288Hiral Labs Ltd, 265, Sisona, Rookee-247661, IndiaMAPS Pharma (Pvt) LtdregisteredSample does not confirm to USP specifications with respect to the test for uniformity of dosage units.Withdraw the batch
NMRA/CP/P32/QF12/2021
NA
81
8008.06.2021Surgical SpiritDrugo113not mentionedMarketed by : Drugo Pharma, Kandy Road, Hingula, Sri LankaUnregisteredsample is unsatisfactory as the name and address of the manufacturer is not included on the label.Withdraw batch
NMRA/CP/P32/QF13/2021
NA
82
8110.06.2021Paracetamol Tablets BP 500mgNADPTE01State Pharmaceutical Manufacturing Corporation, RathmalanaNARegisteredSample is considered unsatisfactory due to presence of brown patches on the surface of some tablets in intact packsWithdraw the batch
NMRA/CP/P32/QF17/2019
manufacturer explanation is unsatisfactory
83
8218.06.2021Yellow Soft Paraffin BPSofskinKCL-J-144LIM Chemicals limited, G-13/16. MIDC, Taloja-410208-Unregisteredsample does not confoem to BP specification with respect to labelling. (according to labelling requirement the label states the nominal drop point. But no drop point is stated on the label. Withour this information identificationtest cannot be doneWithdraw tha batch
NMRA/CP/P32/QF14/2021
NA
84
8321.06.2021Flucloxacillin Capsules BP 250mgFlucillin 250NATheon Pharmaceuticals Ltd, Vill.Saini Majra, Tehsil Nalagarh, Dist.Solan (HP)-174101, IndiaSlim Pharmaceuticalsregistered sample is unsatisfactory due to swollen blisters and broken seal.Withdraw product
NMRA/CP/P32/QF22/2020
manufacturer has not sent detail explanation for the previous failure on the same defect
85
8409.07.2021Amitriptyline Tablets 25mgNA2101003Morison Ltd, P O Box 430, 126, Aluthmawatha Road, Colombo 15NAregisteredLabal descripancyVoluntary Recall
NMRA/CP/P32/VR02/2021
NA
86
8513.07.2021Flucloxacillin Capsules BP 250mgFluclox 250LK035Advanced Chemical Industries Limited, 7, Hajeegonj Road, gonnyl Narayangonj, BangladeshCIC Holdings PLCregisteredsample does not conform to BP specification with respect to the Related substance test.withhold the batch
NMRA/CP/P32/QF15/2021
NA
87
8615.07.2021Levothyroxine Sodium Tablets USP 100mcgThyromega 100T2779007 T2779014The ACME Laboratories Ltd, Dhaka, BangladeshMega Pharma Pvt LtdRegisteredsample does not confirm to specification with respect to Uniformity of dosage unit and assayWithdraw batches
NMRA/CP/P32/QF15/2020
explanation submitted by the manufacturer are unsatisfactory
88
8715.07.2021Noradrenaline Injection BP 2mg/2mlNAJN0002ASteril-Gane Life Sciences (P) Ltd, No.45, Mangalam Village, Villianur Commune, Puducherry-605110, Indiapharma AssociatesRegistered sample is unsatisfactory as stength of the drug is stated two different ways in the same label, name of the stated as the label as 'Noradrenaline injection BP 2mg/2ml".However the composition of the sample is stated as "each 2ml contains:Noradrenaline Acid Tartrate BP 4mg" on the same labelWithdraw batch
NMRA/CP/P32/QF16/2021
NA
89
8820.07.2021Low Calcium (2.5mEq/L) Peritonial Dislysis Solution with Dextrose 1.5%w/vPeritoneL10182 L10205C1 L10205C2Peritone Health Sdn.Bhd, Lot 12, Industrial Zone 4, Kulim Hi-Tech Park, Kedah, MalaysiaInfuxion Lanka Pvt LtdRegistered sample is considered unsatisfactory due to leakage observed. It is suspected that above leakages occurred through weak points of the seams which may have not satisfactory sealed during the sealing process or the damages may be due to improper packaging which may not provide the physical protection during storage and transport.withhold the batches
NMRA/CP/P32/QF17/2021
batch withholding decision was revoked based on the NMQAL recommendation on 10.12.2021. the decision was changed to discontinue to use containers which show the defect (Leakage).
90
8920.07.2021Low Calcium (2.5mEq/L) Peritonial Dislysis Solution with Dextrose 2.5%w/vPeritoneL10202Peritone Health Sdn.Bhd, Lot 12, Industrial Zone 4, Kulim Hi-Tech Park, Kedah, MalaysiaInfuxion Lanka Pvt LtdRegistered sample is considered unsatisfactory due to leakage observed. It is suspected that above leakages occurred through weak points of the seams which may have not satisfactory sealed during the sealing process or the damages may be due to improper packaging which may not provide the physical protection during storage and transport.withhold the batch
NMRA/CP/P32/QF18/2021
batch withholding decision was revoked based on the NMQAL recommendation on 10.12.2021. the decision was changed to discontinue to use containers which show the defect (Leakage).
91
9006.08.2021Metoprolol Tartrate Tablets BP 50mgNATM-190024 and TM-190001Centurion remedies Pvt Ltd, G/5 and G/6, Industrial Estate Gorwa, Vadodara-390016, Gujarat, IndiaYaden International Pvt Ltdregistered sample is unsatisfactory due to some tablets break in to pieces when taking out of the blister pack and sample does not conform to BP specifications with respect to Assay testWithdraw the batches
NMRA/CP/P32/QF23/2020
explanation submitted by the manufacturer is unsatisfactory
92
9106.08.2021Deferoxamine Mesilate for Injection USP 500mgDemoferidon1705777Demo S.A.Pharmaceuticals Industry, 21st Km, National Rd, Athens-Lamia. Krioneri, GreeceAccess International Pvt LtdRegisteredsample does not conform to USP specification with respect to the water determinationwithdraw the batch
NMRA/CP/P32/QF21/2018
manufacturer explanation has not been submitted
93
9206.08.2021Flucloxacillin Oral suspension BP 125mg/5mlFloclox Powder for oral suspensionNAAdvanced Chemical Industries Limited, 7, Hajeegonj Road, gonnyl Narayangonj, BangladeshCIC Holdings PLCregisteredsample does not conform to the BP specification with respect to the definitionwithdraw product
NMRA/CP/P32/QF09/2021
NA
94
9311.08.2021Meropenem for injection USP 500mgNAP50906Sanjivani Parenteral limited, R-40, TTCIndl.Area, Rabale, Thane-Belapur Road, Navi Mumbai 400701, IndiaCanoe Medicare Pvt LtdRegisteredSample does not confirm to USP specifications with respect to the test for uniformity of dosage units and assaywithdraw the batch
NMRA/CP/P32/QF08/2021
manufacturer explanation has not been submitted
95
9412.08.2021Amoxicillin and Clavulanate Potassium Tablets USP 375 mgAvam 375T19IAB03AMN Life Science Pvt Ltd, 150, Sahajanand Estate, Sarkhej, Tal City. Ahmedabad, Gujarat State, Indiapharma AssociatesRegisteredall intact blisters in the alluminium blister packs are swallen and deformedwithdraw the batch
NMRA/CP/P32/QF16/2020
manufacturer explanation has not been submitted
96
9523.08.2021Cyclophosphomide tablets BP 50mgNAAT-010221BDH Industries Ltd, Nair Baug.Akurli Road, Kandivli (East),Mumbai 400101, IndiaRavilux Company (Pvt) LtdRegisteredSample is considered unsatisfactory due to presence of brown patches on the surface of some tablets in intact packswithdraw the batch
NMRA/CP/P32/QF10/2021
manufacturer explanation has not been submitted
97
9623.08.2021Calamine BP 500gNACA-001Neelkanth Minechem, India-UnregisteredSample is considered unsatisfactory due to discrepancies observed on the label for storage condition.withdraw the batch
NMRA/CP/P32/QF33/2020
manufacturer explanation has not been submitted
98
9724.08.2021Furosemide Inj BP 10mg/mlNA20F01Pharmafabrikon, Unit II, 91-1, Sivagangai Road, Vilathur, Maduari 625020, IndiaNovachem Lanka Pvt Ltdregisteredsample does not conform to BP specifications with respect to Assay testwithhdraw the batch
NMRA/CP/P32/QF28/2020
manufacturers explanation could not be accepted.
99
9831.08.2021Hydrogen PeroxideNA99not mentionedMarketed by : Drugo Pharma, Kandy Road, Hingula, Sri LankaUnregisteredsample is unsatisfactory due to deficiencies in the label. Product strength, manufacturer, storage condition are not included on the label and the spelling error in the product.withdraw the batch
NMRA/CP/P32/QF19/2021
NA
100
9901.09.2021Dobutamine Injection USP 250mg/20mlNA19364802Mercury Laboratories Ltd, Unit No.1,2/13-14, Gorwa industrial Estate, Gorwa, Vadodara-390016, Gujarat, IndiaYaden International Pvt LtdRegisteredColor variation among vials of the same batchWithdraw the batch
NMRA/CP/P32/QF24/2019
manufacturers explanation could not be accepted.