Status
Ongoing
Drug Enforcement D-0527-2023
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, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9
- Product quantity
- 15 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-0527-2023
- Event ID
- 91952
- Recall initiation date
- March 23, 2023
- Center classification date
- April 6, 2023
- Code info
- Lot: H1221Z, I0121J, J0622X, Exp 10/31/2023.
- More code info
- —