The Recall Desk
ModerateFDA (Drugs)·D-0495-2023·Announced 2023-04-12

Drug Recall: Rosuvastatin 5mg Tablets for Manufacturing Deviations

RemedyRepack Inc. is recalling 399 bottles of Rosuvastatin 5mg tablets nationwide due to manufacturing deviations. No illnesses have been reported.

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 a FDA Class II voluntary recall with manufacturing deviations but no reported illnesses or injuries. Per the rubric, voluntary precautionary recalls with no reported incidents score as Moderate.

Plain-English summary

RemedyRepack Inc. is recalling 399 bottles of Rosuvastatin 5mg tablets due to manufacturing deviations. The recalled product was distributed nationwide to consignees. Affected lot numbers include J0668398-121422 (expiring 12/31/2023), J0661225-111522 and J0654053-101822 (expiring 11/30/2023), and J0646383-091422 (expiring 09/30/2023).

The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations identified during the manufacturing process. This is a voluntary recall initiated by the firm.

No illnesses or injuries have been reported related to this product. The recall was initiated on March 20, 2023, and terminated on October 19, 2023. Healthcare providers and consumers who have this prescription medication should contact their pharmacist or healthcare provider for guidance.

The recalled product

Product
Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00.
Manufacturer
RemedyRepack Inc.
Category
Drug — Statin
Hazard
Affected units
399

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 (6)

  • Lot #: J0668398-121422
  • Exp. Date 12/31/2023
  • J0661225-111522
  • J0654053-101822 Exp. Date 11/30/2023
  • J0646383-091422
  • Exp. Date 09/30/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by RemedyRepack Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

Related recalls

Same manufacturer · RemedyRepack Inc.

See all →

Same hazard · manufacturing deviation

See all →