FDA recall D-1058-2014

Product

Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66

Reason for recall

Failed Dissolution Specification; 8 hr stability timepoint

Distribution

US nationwide (including PR)

Key facts

Status

Terminated

Initiation date

2013-11-04

Report date

2014-02-12

Termination date

2015-06-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1058-2014