D-0517-2023 Class II Ongoing
FDA drug recall D-0517-2023 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: 17 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 12, 2023
- Initiation Date
- Mar 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 Bottles
Product Description
Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8095-9
Reason for Recall
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Distribution Pattern
USA Nationwide
Code Information
Lot: D0122K, Exp. Date: 6/30/2024; Lot: I1422N, Exp. Date: 9/30/2024; Lot: I2721B, Exp. Date: 1/31/2024.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0517-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026