Drug product
Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- NDC 59762-0541-2
D-0010-2019
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 81028
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7777 bottles
- Official record key
drug-enforcement:D-0010-2019
Official wording
Reason: CGMP Deviations; rejected product was used to manufacture final bulk lot
Code information: Lot: T71137 Exp. Feb. 2022
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations