The Recall Desk
HighFDA (Drugs)·D-0520-2023·Announced 2023-04-12

Rosuvastatin Tablets Recalled Due to Manufacturing Deviations

Preferred Pharmaceuticals is recalling 264 bottles of Rosuvastatin Tablets 5mg nationwide due to manufacturing deviations discovered during FDA inspection. No illnesses have been reported.

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 for manufacturing deviations discovered during FDA inspection. The absence of reported illnesses or injuries limits the score to a maximum of 3 per the rubric, despite the serious nature of systematic process control violations.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling 264 bottles of Rosuvastatin Tablets, USP, 5mg (30-count bottles) distributed nationwide in the United States. The recall is due to Current Good Manufacturing Practice (cGMP) deviations identified at the manufacturing facility, Accord Healthcare, Inc., during an FDA inspection. These deviations indicate that manufacturing processes did not meet FDA standards for pharmaceutical production.

Patients taking this medication should consult with their pharmacist or doctor before taking any action regarding their current supply. No illnesses or adverse events related to this recall have been reported. The affected lot numbers are: A1723C (expires 8/31/2025), A1922B (expires 6/30/2024), D0622M and F2922I (expires 7/31/2024), G3021L (expires 1/31/2024), and H2622P and J0722C (expires 10/31/2024).

The recalled product

Product
Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3
Manufacturer
Preferred Pharmaceuticals, Inc.
Category
Drug — Prescription Cardiovascular
Hazard
Affected units
264

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 (10)

  • Lot: A1723C
  • Exp 8/31/2025
  • Lot: A1922B
  • Exp 6/30/2024
  • Lot: D0622M and Lot: F2922I
  • Exp 7/31/2024
  • Lot: G3021L
  • Exp 1/31/2024
  • Lot:H2622P & Lot: J0722C
  • Exp 10/31/2024.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by Preferred Pharmaceuticals, 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 17 products in this recall →

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