Recalls / Class II
Class IID-0476-2017
Product
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
- Affected lot / code info
- 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
Why it was recalled
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Recalling firm
- Firm
- Actavis Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 499320 units
- Distribution pattern
- Nationwide in US
Timeline
- Recall initiated
- 2017-01-30
- FDA classified
- 2017-02-15
- Posted by FDA
- 2017-02-22
- Terminated
- 2018-03-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0476-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.