February 2013 FDA Recall Ethambutol Hydrochloride by Lupin Pharmaceuticals Inc.
D-346-2014 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on February 22, 2013 for the product Ethambutol Hydrochloride. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-346-2014
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
02-22-2013
12-18-2013
4896 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
12-30-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : 3122856, Exp 05/14
