PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: August 16, 2017 Initiated: August 2, 2017 #D-1058-2017

Product Description

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.

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
2,880 cartons (30 unit dose blister pack per carton)
Distribution
Product distributed to OH, IL, PA, MI, VA and CT
Location
North Wales, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by Teva Pharmaceuticals USA. Units affected: 2,880 cartons (30 unit dose blister pack per carton).
Why was this product recalled?
Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 16, 2017. Severity: Low. Recall number: D-1058-2017.