Class II · Moderate risk Terminated
Tobramycin for Injection
Reason 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."
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,
- 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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Tobramycin recalls
See all
Class III · Low risk Ongoing
Tobramycin Opthalmic Solution USP
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Tobramycin Ophthalmic Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Tobramycin Inhalation Solution USP
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Terminated
Tobramycin 660mg in Ns 66ml
Reason Lack of sterility assurance
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