Key Takeaway

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 Pharmac by Teva Pharmaceuticals USA was recalled on August 2, 2017. The hazard: Failed Moisture Limits: out of specification test results for water content obtained during stability testing.

FDA Drug 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 Pharmac

Recalled: August 2, 2017 ~2,880 cartons (30 unit dose blister pack per carton) units affected D-1058-2017

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

Hazard / Reason

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

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

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 Pharmac

Drugs

Company Information

Teva Pharmaceuticals USA

Horsham, PA, United States

View all 196 recalls by Teva Pharmaceuticals USA →

Distribution

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

Related Recalls

Frequently Asked Questions

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