FDA recall D-0476-2017

Product

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

Reason for recall

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

Distribution

Nationwide in US

Key facts

Status

Terminated

Initiation date

2017-01-30

Report date

2017-02-22

Termination date

2018-03-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

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