Recalls / Class II
Class IID-0522-2023
Product
Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9747-9
- Affected lot / code info
- Lot: C2222P, D1522L, E3122D, G2522J, Exp 9/30/2023; Lot: J1222R, Exp 10/31/2023.
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
- 82 Bottles of 90 Tablets
- 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-0522-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.