Class II
Terminated
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
This recall has been terminated (originally issued March 25, 2015).
- Recall Initiated
- March 10, 2015
- Posted
- March 25, 2015
- Recall Number
- D-0414-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 23246 bottles
- Firm Location
- Philadelphia, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: during long-term stability testing.
Distribution
Nationwide
Lot / Code Info
Lot #: 6557301, Exp 3/15; 6557401, Exp 3/15; 6557501, Exp 3/15; 6656301, Exp 10/16; 6687701, Exp 4/17.
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