Recall: D-346-2014

Class III - Minor Violations

Class IIIClassification

2013-02-22Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

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

Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.