Recalls / Class II
Class IID-0520-2023
Product
Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3
- Affected lot / code info
- 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.
Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, Anaheim, California 92807-1801
Distribution
- Quantity
- 264 Bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2023-03-23
- FDA classified
- 2023-04-06
- Posted by FDA
- 2023-04-12
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0520-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.