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
Reported: February 22, 2017 Initiated: January 30, 2017 #D-0476-2017
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.
Details
- Recalling Firm
- Actavis Inc
- Units Affected
- 499320 units
- Distribution
- Nationwide in US
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Actavis Inc. Units affected: 499320 units.
Why was this product recalled? ▼
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 22, 2017. Severity: Moderate. Recall number: D-0476-2017.
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