Class III
Terminated
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.
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- February 22, 2013
- Posted
- December 18, 2013
- Recall Number
- D-346-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4896 bottles
- Firm Location
- Baltimore, MD, United States
Reason for Recall
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Distribution
Nationwide
Lot / Code Info
Lot #: 3122856, Exp 05/14
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