Recalls / Class II
Class IID-1457-2016
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
- Affected lot / code info
- Lot # 3132593, 3132594, 3134420, 3134421,3134422, Exp. 02/17
Why it was recalled
Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for 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
- 167,152 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-06-30
- FDA classified
- 2016-08-15
- Posted by FDA
- 2016-08-24
- Terminated
- 2017-07-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1457-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.