Recalls / Class II
Class IID-0520-2017
Product
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
- Affected lot / code info
- Lot #160133, 160549 Exp. 08/17 Lot #162006; Exp. 09/17 Lot #163348A, 163348B; Exp. 10/17
Why it was recalled
Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Recalling firm
- Firm
- Amerisource Health Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 19,393 cartons (581,790 extended release tablets)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-02-03
- FDA classified
- 2017-03-14
- Posted by FDA
- 2017-03-22
- Terminated
- 2018-03-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0520-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.