Status
Ongoing
Drug Enforcement D-0517-2023
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Classification
Class II
Report Date
April 12, 2023
Termination Date
—
Product Information
- Product description
- Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8095-9
- Product quantity
- 17 Bottles
- Reason for recall
- cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- USA Nationwide
Location & Firm
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Address
-
1250 N Lakeview Ave Ste O
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0517-2023
- Event ID
- 91952
- Recall initiation date
- March 23, 2023
- Center classification date
- April 6, 2023
- Code info
- Lot: D0122K, Exp. Date: 6/30/2024; Lot: I1422N, Exp. Date: 9/30/2024; Lot: I2721B, Exp. Date: 1/31/2024.
- More code info
- —