Drug product
Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by MUTUAL PHARMACEUTICAL CO., INC., PHILADELPHIA, PA 19124 USA for Sun Pharmaceutical Industries, Inc. 270 Prospect Plains Road, Cranbury, NJ 08512. NDC 53489-281-01
D-0414-2015
Product summary
- Event
- Event 70711
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23246 bottles
- Official record key
drug-enforcement:D-0414-2015
Official wording
Reason: Failed Impurities/Degradation Specifications: during long-term stability testing.
Code information: Lot #: 6557301, Exp 3/15; 6557401, Exp 3/15; 6557501, Exp 3/15; 6656301, Exp 10/16; 6687701, Exp 4/17.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications