Why it was recalled
Failed Impurities/Degradation Specifications: during long-term stability testing.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 6557301, Exp 3/15; 6557401, Exp 3/15; 6557501, Exp 3/15; 6656301, Exp 10/16; 6687701, Exp 4/17.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0414-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 10, 2015
- FDA report date
- Mar 25, 2015
- Quantity
- 23246 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mutual Pharmaceutical Company, Inc.
Original FDA data
Every field from FDA enforcement report D-0414-2015, exactly as published.
Show all FDA fields
- City
- Philadelphia
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 70711
- Address
- 1100 Orthodox St
- Code information
- Lot #: 6557301, Exp 3/15; 6557401, Exp 3/15; 6557501, Exp 3/15; 6656301, Exp 10/16; 6687701, Exp 4/17.
- Postal code
- 19124-3168
- Report date
- Mar 25, 2015
- Product type
- Drugs
- Recall number
- D-0414-2015
- Classification
- Class II
- Recalling firm
- Mutual Pharmaceutical Company, Inc.
- Product quantity
- 23246 bottles
- Termination date
- Jul 15, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications: during long-term stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 10, 2015
- Initial firm notification
- Letter
- Center classification date
- Mar 16, 2015