FDA Drug recall D-346-2014
Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Marylan…
- FDA Drug
- Class III
- terminated
- Published 2013-12-18
On 2013-12-18 the FDA classified a Class III recall of Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Marylan… by Lupin Pharmaceuticals, citing failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-346-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-02-22 |
| Published | 2013-12-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
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.
Reason
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Identifiers
| upc | 368180281016 |
|---|---|
| ndc | 68180-280-01 |
| ndc | 68180-281-01 |
| ndc | 68180-281-02 |
| ndc | 68180-281-11 |
| code_info | Lot #: 3122856, Exp 05/14 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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All Lupin Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-346-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.