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.
Reported: December 18, 2013 Initiated: February 22, 2013 #D-346-2014
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.
Reason for Recall
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 4896 bottles
- Distribution
- Nationwide
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 4896 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 18, 2013. Severity: Low. Recall number: D-346-2014.
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