CLASS III Drug recall · Reported 21 Nov 2012 · FDA Enforcement Report
Tobramycin Ophthalmic Oint., 3%, (Generic for: Tobrex) recalled
Stat Rx U is recalling Tobramycin Ophthalmic Oint., 3%, (Generic for: Tobrex), distributed in Florida, Pennsylvania, Virginia. The recall was initiated on 18 Jun 2012 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
Timeline
| 18 Jun 2012 | Recall initiated by company | |
| 9 Nov 2012 | Classified by FDA | +144 days |
| 21 Nov 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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,
Where it was distributed
FL, PA, and VA.
Questions about this recall
Is Tobramycin Ophthalmic Oint., 3%, (Generic for: Tobrex) recalled?
Yes. Stat Rx U recalled Tobramycin Ophthalmic Oint., 3%, (Generic for: Tobrex) on 18 Jun 2012. The recall is Class III and its status is Terminated. Recall number D-050-2013.
Why was it recalled?
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
Which lots are affected?
Lot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14
Where was it sold?
FL, PA, and VA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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