FDAFDA · Food and drugs·Recall number D-0476-2017
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
Published February 22, 2017 · Recall initiated: January 30, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Actavis Inc
- Distributor
- Nationwide in US
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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