The Recall Desk
HighFDA (Drugs)·D-0412-2023·Announced 2023-03-08

Accord Healthcare Simvastatin 80 mg Tablets Recalled for Manufacturing Practice Violations

Accord Healthcare is recalling Simvastatin 80 mg tablets due to manufacturing practice deviations discovered during an FDA inspection. Approximately 205,631 bottles are affected across the US, Puerto Rico, and Canada.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for manufacturing practice deviations that could affect drug quality and safety. No illnesses or injuries have been reported, but the potential for harm from compromised manufacturing processes warrants the High rating.

Plain-English summary

Accord Healthcare, Inc. is recalling Simvastatin (SIMVASTATIN) 80 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations discovered during an FDA inspection. CGMP violations indicate manufacturing processes that do not meet federal standards for ensuring drug quality, purity, strength, and safety.

The recall involves approximately 205,631 bottles distributed across the United States, including Puerto Rico and Canada. The affected products include 90-count bottles (NDC 16729-007-15) and 1,000-count bottles (NDC 16729-007-17). These tablets were manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India, and are distributed by Accord Healthcare, Inc., based in Durham, North Carolina.

The recall encompasses multiple batch numbers with expiration dates ranging from February 2023 through April 2025. Patients currently taking this medication should consult their healthcare provider for guidance.

The recalled product

Product
SIMVASTATIN (SIMVASTATIN)
Brand
SIMVASTATIN
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Prescription / Cardiovascular
Hazard
Affected units
205,631

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) R2100387
  • R2100393
  • Exp. Date 2/28/2023
  • P2102556
  • P2102558
  • P2102636
  • Exp. Date 4/30/2023
  • P2103981
  • P2103877
  • P2103958
  • Exp. Date 5/31/2023
  • R2101393
  • R2101395
  • R2101394
  • Exp. Date 10/31/2023
  • P2202681
  • P2202653
  • Exp. Date 4/30/2025
  • b)R2000555
  • R2000587

UPCs (2)

  • 316729007153
  • 316729007177

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 67 recalled by Accord Healthcare, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 67 products in this recall →

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