Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4

FDA recall notice · announced February 22, 2017 · Actavis

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.

Notes

Distribution: Nationwide in US
Lot/code information: Lot #: 3134201, 3134202, Exp. 06/30/17; 3134319, Exp. 05/31/17; 3135246, Exp. 07/31/17; 3135247, 3136781, Exp. 08/31/17; 3136782, Exp. 09/30/17; 3136903, 3136904, Exp.10/31/17; 3138250, Exp. 07/31/17; 3138968, Exp. 08/31/17; 3140000, Exp. 09/30/17
Quantity: 499320 units
Status: Terminated
Products in this recall event:
- Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4 (D-0476-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.