Recalls / Class III
Class IIID-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.
- Brand name
- Ethambutol Hydrochloride
- Generic name
- Ethambutol Hydrochloride
- Active ingredient
- Ethambutol Hydrochloride
- Route
- Oral
- NDCs
- 68180-280, 68180-281
- FDA application
- ANDA078939
- Affected lot / code info
- Lot #: 3122856, Exp 05/14
Why it was recalled
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 4896 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-02-22
- FDA classified
- 2013-12-12
- Posted by FDA
- 2013-12-18
- Terminated
- 2013-12-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-346-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.