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.
Recall initiated: 20130222
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated