The Recall Desk
ModerateFDA (Drugs)·D-0380-2023·Announced 2023-03-08

Clopidogrel Tablets Recalled Due to Manufacturing Practice Deviations

Accord Healthcare is recalling Clopidogrel Tablets USP 75 mg due to manufacturing practice deviations found during an FDA inspection. Approximately 1.4 million bottles distributed across the US, Puerto Rico, and Canada are affected.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall for manufacturing practice deviations without any reported illnesses, injuries, or deaths. CGMP deviations represent a precautionary quality control issue; without evidence of actual harm or specific identified hazards, this constitutes a moderate, precautionary recall.

Plain-English summary

Accord Healthcare, Inc. is recalling Clopidogrel Tablets USP, 75 mg, a prescription medication. The affected product is distributed in three package sizes: 30-count bottles (NDC 16729-218-10), 90-count bottles (NDC 16729-218-15), and 500-count bottles (NDC 16729-218-16). The recall encompasses approximately 1,420,988 bottles distributed throughout the United States, including Puerto Rico and Canada.

The recall is being issued due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection of the manufacturing facility. The product was manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India, for Accord Healthcare, Inc., in Durham, North Carolina.

Multiple batches are affected, with expiration dates ranging from February 2023 through July 2024. These batches are identified by specific lot numbers listed in the FDA recall notice.

Patients taking this medication should consult their healthcare provider or pharmacist regarding their prescription. Healthcare providers and pharmacies should check their inventory for affected batch numbers and follow appropriate recall procedures.

The recalled product

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
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Prescription Antiplatelet
Hazard
  • manufacturing-quality-issue

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • R2000653
  • Exp. Date 9/30/2023
  • R2000652
  • R2000826
  • Exp. Date 10/31/2023

Distribution

Distribution scope not specified by the agency.

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