Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30
FDA recall notice · announced August 24, 2016 · Actavis
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30
Reason for recall
Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Notes
Distribution: Nationwide
Lot/code information: Lot # 3132593, 3132594, 3134420, 3134421,3134422, Exp. 02/17
Quantity: 167,152 bottles
Status: Terminated
Products in this recall event:
- Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30 (D-1457-2016)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.