Recalls / Class II
Class IID-0525-2023
Product
Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
- Affected lot / code info
- a) Lot: B0922G, Exp. Date: 5/31/2023, F0322G, Exp. Date: 7/25/2024, H2622M, Exp. Date: 8/31/2024, J1422B, K0722G, Exp. Date: 10/31/2024, L1922A, Exp. Date: 2/28/2025; b) Lot: F2922S, Exp. Date: 8/31/2023, H0322G Exp. Date: 7/31/2023; c) Lot: A1322I, Exp. Date: 3/31/2023, H1122C, Exp. Date: 8/31/2024.
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
- a) 88 Bottles, b) 3 Bottles, c) 175 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-0525-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.