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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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;
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Accord Healthcare, Inc.
Reason for Recall:
CGMP Deviations: recalling drug products following an FDA inspection.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0380-2023

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