Class II · Moderate risk Terminated
glipiZIDE
Reason Failed Dissolution Specifications:
GlipiZIDE Extended-release tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
What was recalled
GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21
- Recalling firm
- Amerisource Health Services
- NDC code
- 68084-295-21
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0520-2017
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
Reason Failed Dissolution Specifications: results were above specification.
Class II · Moderate risk Terminated
GlipiZIDE Extended-release Tablets
Reason Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
Class II · Moderate risk Terminated
Glipizide XL
Reason CGMP Deviations; rejected product was used to manufacture final bulk lot
Class III · Low risk Terminated
Glipizide Extended-Release Tablets
Reason Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
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