Drug product
Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66
D-1058-2014
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 66816
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14,357 bottles
- Official record key
drug-enforcement:D-1058-2014
Official wording
Reason: Failed Dissolution Specification; 8 hr stability timepoint
Code information: Lot V120131
Distribution pattern: US nationwide (including PR)
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specification