FDA-Drug2021-10-27Class II
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)
American Health Packaging
Hazard
Failed Dissolution Specifications: results were above specification.
Sold states
Nationwide within the USA
Affected count
2,266 cartons
Manufactured in
2550 John Glenn Ave Ste A, N/A, Columbus, OH, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0020-2022Don't want to check this manually?
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