D-1457-2016 Class II Terminated
FDA drug recall D-1457-2016 was initiated by Actavis Inc on Jun 30, 2016 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point. The recall status is terminated (terminated Jul 3, 2017). Affected quantity: 167,152 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Aug 24, 2016
- Initiation Date
- Jun 30, 2016
- Termination Date
- Jul 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 167,152 bottles
Product description
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.
Distribution pattern
Nationwide
Code information
Lot # 3132593, 3132594, 3134420, 3134421,3134422, Exp. 02/17
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1457-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026