FDAFDA · Food and drugs·Recall number D-346-2014
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.
Published December 18, 2013 · Recall initiated: February 22, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ETHAMBUTOL HYDROCHLORIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Nationwide
- UPC
- 0368180281016
- Lot
- Lot #: 3122856, Exp 05/14
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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