Ethambutol Hydrochloride Tablets USP recall: Impurity Out of Spec
Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202…
Why was Ethambutol Hydrochloride Tablets USP recalled?
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 3122856, Exp 05/14
- Product
- Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202…
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 4896 bottles
- Distribution
- Nationwide
- Recall date
- December 18, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)