D-1058-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 16, 2017
- Initiation Date
- August 2, 2017
- Termination Date
- February 28, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,880 cartons (30 unit dose blister pack per carton)
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.
Distribution Pattern
Product distributed to OH, IL, PA, MI, VA and CT
Code Information
Lot # 3138405A, Exp 8/2017