D-0476-2017 Class II Terminated
FDA drug recall D-0476-2017 was initiated by Actavis Inc on Jan 30, 2017 and is designated Class II. Reason for recall: Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point. The recall status is terminated (terminated Mar 13, 2018). Affected quantity: 499320 units.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 22, 2017
- Initiation Date
- Jan 30, 2017
- Termination Date
- Mar 13, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 499320 units
Product description
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
Reason for recall
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Distribution pattern
Nationwide in US
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0476-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026