Recalls / Class II
Class IID-0414-2015
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
- Affected lot / code info
- Lot #: 6557301, Exp 3/15; 6557401, Exp 3/15; 6557501, Exp 3/15; 6656301, Exp 10/16; 6687701, Exp 4/17.
Why it was recalled
Failed Impurities/Degradation Specifications: during long-term stability testing.
Recalling firm
- Firm
- Mutual Pharmaceutical Company, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1100 Orthodox St, Philadelphia, Pennsylvania 19124-3168
Distribution
- Quantity
- 23246 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-03-10
- FDA classified
- 2015-03-16
- Posted by FDA
- 2015-03-25
- Terminated
- 2016-07-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0414-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.