The Recall Desk
ModerateFDA (Drugs)·D-0503-2023·Announced 2023-04-12

Drug Recall: Simvastatin tablets due to manufacturing deviations

RemedyRepack Inc. is recalling Simvastatin 40 mg tablets nationwide due to manufacturing deviations. The voluntary recall was initiated in March 2023.

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 recall meets the rubric criterion for Score 2 (Moderate): a voluntary precautionary recall with FDA Class II classification and no reported illnesses or injuries.

Plain-English summary

RemedyRepack Inc. is recalling Simvastatin 40 mg tablets distributed nationwide within the United States. The recalled product was packaged in two formats: 30-count bottles (NDC 70518-0060-01) and 90-count bottles (NDC 70518-0060-00).

The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations. The specific nature of these manufacturing deviations was not disclosed in the FDA notice.

Multiple lot numbers are affected, with expiration dates ranging from July 2023 through March 2025. The recall was voluntary and initiated by RemedyRepack Inc. on March 20, 2023, with the FDA classifying it as Class II on March 31, 2023. The recall was terminated on October 19, 2023.

Consumers with affected Simvastatin tablets should consult their healthcare provider or pharmacist about whether their medication may be involved and what steps to take.

The recalled product

Product
Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
Manufacturer
RemedyRepack Inc.
Category
Drug — 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)

  • Lot # a): J0656821-103122
  • Exp. Date 11/30/2023
  • J0638547-080922
  • Exp. Date 08/31/2023
  • J0633575-071822
  • Exp. Date 07/31/2023 Lot #: b): B1965081-111622
  • Exp. Date 03/31/2025
  • B1857922-091922
  • B1765298-071322
  • B1786319-072922
  • B1706842-053122
  • Exp. Date 04/30/2023
  • B2003311-120822
  • Exp. Date 04/30/2025
  • B1955679-111122
  • Exp. Date 02/28/2025
  • B1878942-092922
  • Exp. Date 11/30/2024
  • B1823203-082622. Exp. Date 10/31/2024
  • B1706843-053122

Distribution

Distributed nationwide across the United States.

Related recalls

Same category