FDA-Drug2013-12-18Class III
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.
Lupin Pharmaceuticals Inc.
Hazard
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Sold states
Nationwide
Affected count
4896 bottles
Manufactured in
111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-346-2014Don't want to check this manually?
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