Tobramycin Ophthalmic Oint — Class III drug recall D-050-2013
Terminated recall by Stat Rx USA, reported 2012-11-21, distributed in FL, PA, VA. Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" inste
| Recall number | D-050-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stat Rx USA, Gainesville, GA, United States |
| Recall initiated | 2012-06-18 |
| Classified | 2012-11-09 |
| Reported by FDA | 2012-11-21 |
| Terminated | 2013-01-31 |
| Distributed | FL, PA, VA |
| Quantity | 22 units |
| Reason classes | labeling |
| NDC | 16590-0224-05 |
| Lot numbers | 06JN1265, 06JN1266, 3/14, 4/14 |
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 for recall
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-050-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.