Class II · Moderate risk Terminated
glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health…
Reason Failed Dissolution Specifications:
Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
What 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
- Recalling firm
- Actavis Inc
- NDC code
- 0591-0900-30
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0476-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Glipizide recalls
See all
Class II · Moderate risk Terminated
GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only…
Reason Failed Dissolution Specifications: results were above specification.
Class II · Moderate risk Terminated
GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health…
Reason Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at…
Class II · Moderate risk Terminated
Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ…
Reason CGMP Deviations; rejected product was used to manufacture final bulk lot
Class III · Low risk Terminated
Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx only, Mfd…
Reason Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
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