Recalls / Class II
Class IID-1276-2019
Product
GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-295-21
- Affected lot / code info
- Lot # 181288, EXP 5/31/2020
Why it was recalled
Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 2,203 cartons (cartons of 30 individual unit doses)
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-04-08
- FDA classified
- 2019-05-10
- Posted by FDA
- 2019-05-08
- Terminated
- 2020-11-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1276-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.