FDA Drug recall D-050-2013
Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 1659…
- FDA Drug
- Class III
- terminated
- Published 2012-11-21
On 2012-11-21 the FDA classified a Class III recall of Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 1659… by Stat Rx Usa, citing labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution.".
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-050-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-06-18 |
| Published | 2012-11-21 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Stat Rx Usa |
| Distribution | FL, PA, VA |
Product
Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05,
Reason
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
Identifiers
| code_info | Lot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-050-2013%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.