Lupin Pharmaceuticals Inc. recalls Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc.,
Recalled December 18, 2013 · FDA recall D-346-2014 · Lupin Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity. · FDA Class III
Units
4896 bottles
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
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.
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →