FDA recall D-346-2014

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-02-22

Report date

2013-12-18

Termination date

2013-12-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-346-2014