Drug 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.
D-346-2014
Product summary
- Event
- Event 66065
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4896 bottles
- Official record key
drug-enforcement:D-346-2014
Official wording
Reason: Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Code information: Lot #: 3122856, Exp 05/14
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification