The Recall Desk
HighFDA (Drugs)·D-0501-2023·Announced 2023-04-12

Rosuvastatin 10mg tablets recalled for manufacturing process deviations

RemedyRepack Inc. is recalling Rosuvastatin 10mg tablets due to cGMP deviations in the manufacturing process. The recall affects 30-count and 90-count bottles distributed nationwide.

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 recalls indicate serious health risk is possible though not probable. No illnesses or injuries have been reported. The cGMP deviations represent a quality control issue rather than a confirmed product hazard.

Plain-English summary

RemedyRepack Inc. is recalling Rosuvastatin 10mg tablets in both 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and 90-count bottles (NDC 70518-0375-00).

The recall was initiated on March 20, 2023, due to cGMP (current Good Manufacturing Practice) deviations in the manufacturing and repackaging process. The firm voluntarily initiated this recall.

A total of 399 bottles of the 30-count product and 445 bottles of the 90-count product were distributed nationwide by RemedyRepack to consignees throughout the United States. Specific lot numbers and expiration dates for affected batches are documented in the recall notice.

The FDA classified this as a Class II recall, and the recall was terminated on October 19, 2023.

The recalled product

Product
Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Manufacturer
RemedyRepack Inc.
Category
Drug — Statin
Hazard
  • cGMP-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 (16)

  • Lot#: a) NDC 70518-0375-03: J0674788-011123
  • Exp. Date 01/31/2024
  • J0664118-112922 J0664118-112922
  • Exp. Date 12/31/2023
  • J0653727-101722
  • Exp. Date 10/31/2023. NDC 70518-0375-01: B2057931-011223
  • Exp. Date 07/31/2025 b) Lot #: B2075815-012523
  • Exp. Date 09/30/2025
  • B2011634-121322
  • Exp. Date 07/31/2025 B1970205-112022
  • Exp. Date 06/30/2024
  • B1862598-092022
  • Exp. Date 03/31/2024
  • B2077226-012523
  • B2070444-012023
  • Exp. Date 07/31/2025.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category