The Recall Desk
ModerateFDA (Drugs)·D-0491-2023·Announced 2023-04-12

Drug Recall: Atorvastatin 10 mg tablets due to manufacturing process violations

RemedyRepack Inc. is recalling specific lots of Atorvastatin 10 mg tablets distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The voluntary recall was initiated March 20, 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: FDA Class II classification with no reported illnesses or injuries. The recall is voluntary and concerns manufacturing process deviations without a specific identified safety hazard, meeting the criteria for Moderate severity as a precautionary recall.

Plain-English summary

RemedyRepack Inc. is recalling specific lots of Atorvastatin 10 mg tablets due to current Good Manufacturing Practice (cGMP) deviations discovered in the manufacturing process. The product was distributed nationwide in 30-count bottles (NDC 70518-1946-00) and 90-count bottles (NDC 70518-1946-01).

The firm initiated this voluntary recall on March 20, 2023. The cGMP deviations relate to how the medication was manufactured, which can affect product quality and safety. A total of 3,497 bottles of 30-count packaging and 729 bottles of 90-count packaging were recalled.

Patients taking atorvastatin should check the lot number and expiration date on their bottle against the list of affected lots in the FDA recall notice. Those with recalled medication should contact their pharmacy or healthcare provider for guidance. The specific lot numbers and expiration dates are available on the FDA website.

The recall was terminated on October 19, 2023.

The recalled product

Product
Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Manufacturer
RemedyRepack Inc.
Category
Drug — Prescription Tablet
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) J0679046-020123
  • Exp. Date 02/28/2024
  • J0669807-122122
  • Exp. Date 01/31/2024
  • J0662695-112222
  • Exp. Date 12/31/2023
  • J0654076-101822
  • Exp. Date 11/30/2023
  • J0642765-082922
  • Exp. Date 09/30/2023 Lot #: b) B1672408-050322
  • B1765902-071322
  • B1769634-071622
  • Exp. Date 04/30/2023
  • B1776907-072122
  • Exp. Date 09/30/2023
  • B1836636-090322
  • B1870344-092422
  • B1908452-101522
  • B1966455-111722
  • B2043099-010423

Distribution

Distributed nationwide across the United States.

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