The Recall Desk
ModerateFDA (Drugs)·D-0500-2023·Announced 2023-04-12

Rosuvastatin 5mg Tablets Recalled Due to Manufacturing Deviations

RemedyRepack Inc. voluntarily recalled 132 bottles of Rosuvastatin 5mg tablets nationwide due to current Good Manufacturing Practice deviations. No illnesses or injuries 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 Class II drug recall with no reported illnesses or injuries. The recall is voluntary and precautionary, based on manufacturing process deviations rather than a specific identified product defect. Per the FDA rubric, voluntary precautionary recalls without reported harm are classified as Moderate.

Plain-English summary

RemedyRepack Inc. voluntarily recalled 132 bottles of Rosuvastatin 5mg tablets in 30-count bottles (NDC 70518-3519-00) that were distributed nationwide. The affected lot numbers are J0668398-121422 (expiration 12/31/2023), J0661225-111522, J0654053-101822 (expiration 11/30/2023), and J0646383-091422 (expiration 09/30/2023).

The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations identified during the manufacturing process. The FDA classified this as a Class II recall. No illnesses or injuries have been reported related to this product.

Patients who have obtained Rosuvastatin 5mg tablets from the affected lot numbers should consult their healthcare provider or pharmacist to determine if their medication is affected. The firm initiated the recall on March 20, 2023, and the recall was terminated on October 19, 2023.

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 — Prescription Cholesterol Medication
Hazard
Affected units
132

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 →