Recalls / Class II
Class IID-0020-2022
Product
GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21 (Individual Dose NDC: 68084-295-11)
- Affected lot / code info
- Lot #: 194141, Exp. Date 03/31/2022
Why it was recalled
Failed Dissolution Specifications: results were above specification.
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 2,266 cartons
- Distribution pattern
- Nationwide within the USA
Timeline
- Recall initiated
- 2021-09-17
- FDA classified
- 2021-10-20
- Posted by FDA
- 2021-10-27
- Terminated
- 2023-06-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0020-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.