Class II · Moderate risk Terminated
Tobramycin for Injection
Reason Failed Stability Specification: Water determination was found not complying with specification.
Tobramycin 14 mg/mL Ophthalmic Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
What was recalled
Tobramycin 14 mg/mL Ophthalmic Solution, 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
- Recalling firm
- Liberty Drug & Surgical
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1389-2015
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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