Recalls / Class III
Class IIID-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
- Affected lot / code info
- Lot # 3138405A, Exp 8/2017
Why it was recalled
Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 2,880 cartons (30 unit dose blister pack per carton)
- Distribution pattern
- Product distributed to OH, IL, PA, MI, VA and CT
Timeline
- Recall initiated
- 2017-08-02
- FDA classified
- 2017-08-08
- Posted by FDA
- 2017-08-16
- Terminated
- 2018-02-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1058-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.