D-0523-2023 Class II Ongoing
FDA drug recall D-0523-2023 was initiated by Preferred Pharmaceuticals, Inc. on Mar 23, 2023 and is designated Class II. Reason for recall: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. The recall status is ongoing. Affected quantity: 57 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 12, 2023
- Initiation Date
- Mar 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 57 Bottles
Product Description
Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9
Reason for Recall
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Distribution Pattern
USA Nationwide
Code Information
Lot: B0222S, Exp 2/29/2024; Lot: F1121B, G2721L, Exp 11/30/2023.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0523-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026