FDA recall D-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)

Reason for recall

Failed Dissolution Specifications: results were above specification.

Distribution

Nationwide within the USA

Key facts

Status

Terminated

Initiation date

2021-09-17

Report date

2021-10-27

Termination date

2023-06-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0020-2022