The Recall Desk
ModerateFDA (Drugs)·D-0409-2023·Announced 2023-03-08

Simvastatin tablets recalled due to manufacturing process deviations

Accord Healthcare is recalling Simvastatin 10 mg tablets distributed in the U.S., Puerto Rico, and Canada due to manufacturing process deviations discovered during FDA inspection. Patients should contact their pharmacy or healthcare provider.

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: This is an FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard consists of manufacturing process deviations identified during FDA inspection. Per the rubric, when no illnesses or injuries are reported and the hazard is theoretical, the score is at most 3. The precautionary nature of this quality control-based recall places it at Moderate (2).

Plain-English summary

Accord Healthcare, Inc. is recalling Simvastatin 10 mg tablets distributed in the United States, Puerto Rico, and Canada. The recall involves approximately 291,378 bottles in 90-count and 1,000-count packages across multiple batches.

The recall was initiated following an FDA inspection that identified deviations from Current Good Manufacturing Practice (CGMP) requirements. The specific nature of these deviations is not detailed in the available recall information.

Consumers with affected medication should contact their pharmacy or healthcare provider to determine if their specific batch is impacted. Patients should not discontinue their medication without consulting their healthcare provider.

Affected batch numbers and expiration dates can be obtained from the recalling company. Consumers should not discard their medication without professional guidance.

The recalled product

Product
SIMVASTATIN (SIMVASTATIN)
Brand
SIMVASTATIN
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Prescription Statin
Hazard
  • manufacturing-deviation

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) P2106923
  • Exp. Date 9/30/2023
  • R2101544
  • Exp. Date 10/31/2023
  • R2200732
  • Exp. Date 5/31/2025
  • b) P2101634
  • Exp. Date 2/28/2023
  • P2102370
  • Exp. Date 3/31/2023
  • P2102321
  • P2102411
  • P2102454
  • P2103991
  • Exp. Date 5/31/2023
  • R2100954
  • Exp. Date 6/30/2023
  • R2100947
  • R2100951
  • P2106242

UPCs (2)

  • 316729004152
  • 316729004176

Distribution

Distribution scope not specified by the agency.

Related recalls

Same brand · SIMVASTATIN

Same category