Drug Enforcement D-346-2014

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

Status

Terminated

Classification

Class III

Report Date

December 18, 2013

Termination Date

December 30, 2013

Product Information

Product description
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.
Product quantity
4896 bottles
Reason for recall
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Lupin Pharmaceuticals Inc.
Address
111 S Calvert St Fl 21st

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-346-2014
Event ID
66065
Recall initiation date
February 22, 2013
Center classification date
December 12, 2013
Code info
Lot #: 3122856, Exp 05/14
More code info
—