Recalls / Class II
Class IID-0524-2023
Product
Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
- Affected lot / code info
- a) Lot: A0923R, Exp. Date: 2/28/2025, A1222K, B1822C, Exp. Date: 5/31/2024, C3022D, F2322V, Exp. Date: 6/30/2024, H1522H, Exp. Date: 8/31/2024, I1621O, Exp. Date: 1/31/2024, I2222G, J1822R, Exp. Date: 9/30/2024, L1621N, Exp. Date: 5/31/2024; b) Lot: F0822Q, Exp. Date: 6/30/2024, I0122J, Exp. Date: 8/31/2024, L0821C, Exp. Date: 5/31/2024; c) Lot: I1521P, Exp. Date: 1/31/2024, J1322R, Exp. Date: 9/30/2024, J1821H, Exp. Date: 2/29/2024.
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) 305 Bottles, b) 72 Bottles, c) 617 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-0524-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.