CLASS III Drug recall · Reported 21 Nov 2012 · FDA Enforcement Report
Tobramycin Ophthalmic Oint., 0.3%, (Generic for: Tobrex) recalled
Stat Rx USA is recalling Tobramycin Ophthalmic Oint., 0.3%, (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
- Recall number
- D-050-2013
- FDA event ID
- 62940
- Recalling firm
- Stat Rx USA, Gainesville, GA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Jun 2012
- FDA classified
- 9 Nov 2012
- Reported
- 21 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Drug class
- Eye Drops
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."
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
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
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Stat Rx USA
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|---|---|---|---|---|---|
| Drug | CLASS III | Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward recalled | Stat Rx USA | Packaging Defects | PA |
| Drug | CLASS III | Venlafaxine ER 150mg, 30 Tabs, Generic for: Effexor, Packaged recalled | Stat Rx USA | Labeling Errors | GA, TN |
| Drug | CLASS III | Tizanidine (Generic for: Zanaflex), 4 mg recalled by Stat Rx U | Stat Rx USA | Packaging Defects | Nationwide |