The Recall Desk
HighFDA (Drugs)·D-0496-2023·Announced 2023-04-12

Simvastatin 10 mg Tablets Recalled for Manufacturing Practice Deviations

RemedyRepack Inc. voluntarily recalled Simvastatin 10 mg tablets nationwide due to manufacturing practice deviations. The recall affects specific lots distributed to consignees throughout the United States.

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: This is an FDA Class II recall without any reported illnesses or injuries. Per the rubric, a Class II recall without hospitalization reports or confirmed adverse events, where the hazard is theoretical, scores as 'High' (3).

Plain-English summary

RemedyRepack Inc., located in Indiana, Pennsylvania, initiated a voluntary recall of Simvastatin 10 mg tablets due to current Good Manufacturing Practice deviations. The company distributed affected lots to consignees nationwide within the United States.

The recalled product consists of two packaging formats: 30-count bottles (NDC 70518-0064-01, 1,262 units) and 90-count bottles (NDC 70518-0064-00, 95 units). Multiple lots with various expiration dates from April 2023 through February 2025 are included. The recall was initiated March 20, 2023, and terminated October 19, 2023.

Patients who have received affected tablets should contact their healthcare provider or pharmacist for guidance on their Simvastatin therapy.

The recalled product

Product
Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
Manufacturer
RemedyRepack Inc.
Category
Drug
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 (19)

  • Lot #: a) J0675206-011223
  • J0669260-121922
  • Exp. Date 01/31/2024
  • J0656820-103122
  • J0647161-091722
  • Exp. Date 09/30/2023 Exp. Date 11/30/2023
  • J0621491-052722
  • Exp. Date 06/30/2023
  • J0638138-080822
  • Exp. Date 08/31/2023
  • J0610887-041122
  • Exp. Date 04/30/2023. Lot # b) B1887315-100422
  • Exp. Date 02/28/2024
  • B1829906-083122
  • B1769715-071622
  • Exp. Date 09/30/2023
  • B1906605-101422
  • B1965118-111622
  • Exp. Date 02/28/2025.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category