Class II · Moderate risk
Tobramycin for Injection
Failed Stability Specification: Water determination was found not complying with specification.
Tobramycin Ophthalmic Oint.
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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,
Affected NDC
16590-0224-05
Compare with the code on your package — it is the most precise check available.
Drug: Tobramycin Category: Eye Drops & Ophthalmic
- Recalling firm
- Stat Rx USA
- NDC code
- 16590-224-05
- Origin
- GA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-050-2013 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Tobramycin recalls
See all
Class III · Low risk
Tobramycin Opthalmic Solution USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Tobramycin Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Tobramycin Inhalation Solution USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Tobramycin 660mg in Ns 66ml
Lack of sterility assurance
Other recalls by Stat Rx USA
All 2012 recalls
Class III · Low risk
Methocarbamol 750 mg Tablets
Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled with an expiration date of 10/16 instead of 01/16.
Class III · Low risk
Venlafaxine ER 150mg
Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."
Class III · Low risk
Tizanidine
Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
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