D-0527-2023 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- April 12, 2023
- Initiation Date
- March 23, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 Bottles
Product Description
Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9
Reason for Recall
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Distribution Pattern
USA Nationwide
Code Information
Lot: H1221Z, I0121J, J0622X, Exp 10/31/2023.