D-346-2014 Class III Terminated
FDA drug recall D-346-2014 was initiated by Lupin Pharmaceuticals Inc. on Feb 22, 2013 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity. The recall status is terminated (terminated Dec 30, 2013). Affected quantity: 4896 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 18, 2013
- Initiation Date
- Feb 22, 2013
- Termination Date
- Dec 30, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4896 bottles
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.
Distribution Pattern
Nationwide
Code Information
Lot #: 3122856, Exp 05/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-346-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026