FDA recall D-1059-2014

Product

Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2

Reason for recall

Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval

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

Peapack, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1059-2014