Drug recall D-346-2014
Product
Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-281-01, UPC 3 68180 28101 6.
Reason for recall
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Lots and codes
Lot #: 3122856, Exp 05/14
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- Quantity
- 4896 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 22, 2013
- Terminated
- December 30, 2013
Related products
- Ethambutol Hydrochloride – drug information
- NDC 68180-280 Ethambutol Hydrochloride · Ethambutol Hydrochloride 100 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-281 Ethambutol Hydrochloride · Ethambutol Hydrochloride 400 mg/1 · Lupin Pharmaceuticals, Inc.