FDA recall D-0010-2019

Product

Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- NDC 59762-0541-2

Reason for recall

CGMP Deviations; rejected product was used to manufacture final bulk lot

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-09-20

Report date

2018-10-17

Termination date

2020-05-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0010-2019