Drug 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
D-1058-2017
Product summary
- Event
- Event 77881
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,880 cartons (30 unit dose blister pack per carton)
- Official record key
drug-enforcement:D-1058-2017
Official wording
Reason: Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Code information: Lot # 3138405A, Exp 8/2017
Distribution pattern: Product distributed to OH, IL, PA, MI, VA and CT
Derived failure modes
-
Potency or specification failure
out of specification