FDA-Drug2017-02-22Class II

Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4

Actavis Inc
Hazard

Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.

Sold states
Nationwide in US
Affected count
499320 units
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0476-2017

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