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.
Other recalls by Stat Rx Usa
- Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward Pharm
FDA Drug · Class III · 2013-02-13 · Stat Rx Usa - Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-…
FDA Drug · Class III · 2012-11-21 · Stat Rx Usa - Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged…
FDA Drug · Class III · 2012-08-01 · Stat Rx Usa
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.