Clopidogrel Tablets USP recall: CGMP Deviations
Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-count bottles NDC 16729-218-15 UPC 3 16729 21815 3; c) 500-count bottles, NDC 16729-218-16, UPC 3 16729 21816 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Why was Clopidogrel Tablets USP recalled?
CGMP Deviations: recalling drug products following an FDA inspection.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batches: a) P2001925, Exp. Date 3/31/2023; P2003532, Exp. Date 6/30/2023; P2004847, Exp. Date 7/31/2023; R2000856, Exp. Date 11/30/2023; P2100452, Exp. Date 12/31/2023; P2100898, Exp. Date 1/31/2024; P2106273, Exp. Date 9/30/2024; b) R2000578, Exp. Date 7/31/2023; R2000653, Exp. Date 9/30/2023; R2000652, Exp. Date 9/30/2023; R2000826, Exp. Date 10/31/2023; R2000852, Exp. Date 10/31/2023; R2000853, Exp. Date 10/31/2023; R2000827, Exp. Date 11/30/2023; P2100102, Exp. Date,12/31/2023; P2100004, Exp. Date 12/31/2023; P2100450, Exp. Date 12/31/2023; P2100449, Exp. Date 12/31/2023; c)P2001392, P2001393, P2001395, P2001396, P2001397, P2001492, P2001493, P2001494, P2001495, Exp. Date 2/28/2023; P2001863, P2001864, P2001865, P2001924, P2001866, P2001926, P2001927, P2002072, P2002073, P2002071, P2002074, P2002075, P2002392, Exp. Date 3/31/2023; P2002230, P2002233, P2002234, P2002235, P2002274, P2002400, P2002399, P2002398, P2002479, P2002478, P2002481, P2002480, P2002482, P2002483, Exp. Date 4/30/2023; P2002759, P2002758, P2002755, P2002756, P2003058, P2003059, P2003061, P2003060, P2003062, P2003055, Exp. Date 5/31/2023; P2003533, P2003534, P2003535, P2003675, P2003537, P2003536, P2003676, P2003677, P2003678, P2003679, P2003680, P2003909, P2003910, Exp. Date 6/30/2023; P2004010, P2004008, P2004009, P2004232, P2004233, P2004234, Exp. Date 7/31/2023; P2004576, P2004838, R2000614, R2000624, R2000623, R2000615, R2000638, R2000637, R2000642, R2000640, Exp. Date 8/31/2023; R2000644, R2000662, R2000664, R2000643, R2000667, R2000666, R2000670, R2000671, R2000672, P2005692, P2005656, P2005693, P2005691, P2005694, Exp. Date 9/30/2023; P2005840, P2005841, P2005842, P2005843, P2005844, P2005870, P2005925, P2005923, P2005924, P2006007, P2006009, P2006010, P2005845, P2006008, P2006065, Exp. Date 10/31/2023; R2100003, R2100008, R2100010, R2100015, R2100016, R2100017, R2100018, R2100031, R2100022, R2100024, R2100069, R2100070, R2100071, R2100084, R2100080, R2100083, R2100078, R2100082, R2100093, Exp. Date 11/30/2023; P2100109, P2100304, P2100107, P2100103, P2100106, P2100108, P2100305, Exp. Date 12/31/2023; P2100718, P2100721, P2100720, P2100748, Exp. Date 1/31/2024; P2104140, Exp. Date 6/30/2024; P2104861, P2104860, P2104859, P2104866, Exp. Date 7/31/2024;
- Product
- Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-count bottles NDC 16729-218-15 UPC 3 16729 21815 3; c) 500-count bottles, NDC 16729-218-16, UPC 3 16729 21816 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
- Recalling firm
- Accord Healthcare, Inc.
- Quantity
- 1,420,988 bottles
- Distribution
- United States including Puerto Rico and Canada
- Recall date
- March 8, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)