FDA recall D-1058-2017

Product

Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx only, Mfd for: Watson Laboratories, Inc., Corona, CA 92880, Mfd by: Patheon Pharmaceuticals, Inc., Cincinnati, OH 43215, NDC 0591-0844-15

Reason for recall

Failed Moisture Limits: out of specification test results for water content obtained during stability testing.

Distribution

Product distributed to OH, IL, PA, MI, VA and CT

Key facts

Status

Terminated

Initiation date

2017-08-02

Report date

2017-08-16

Termination date

2018-02-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1058-2017