Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30
Reported: August 24, 2016 Initiated: June 30, 2016 #D-1457-2016
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.
Details
- Recalling Firm
- Actavis Inc
- Units Affected
- 167,152 bottles
- Distribution
- Nationwide
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30. Recalled by Actavis Inc. Units affected: 167,152 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 24, 2016. Severity: Moderate. Recall number: D-1457-2016.
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