Reported Dec 18, 2013 · Terminated
Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals,…
Lupin Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · 111 S Calvert St Fl 21st · Baltimore, MD · 21202-6174
Is this the product you have?
- Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only
- Manufactured forLupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States
- Manufactured by
Lupin LimitedMumbai 400 098 INDIANDC 68180-281-01UPC 3 68180 28101 6
- Lot codes and dates
Lot #: 3122856Exp 05/14
- Amount recalled
- 4896 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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