Class II · Moderate risk Terminated
Tobramycin for Injection
Reason Failed Stability Specification: Water determination was found not complying with specification.
Tobramycin 1.4%
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
What was recalled
TOBRAMYCIN 1.4% (14MG/ML) OPHTHALMIC 15 ML 3 ML 7 ML; TOBRAMYCIN SOLUTION** 0.3% OPHTHALMIC 30 MLS 5 MLS; TOBRAMYCIN SULFATE** (25X2ML) 80MG/2ML INJECTABLE 100 ML 150 ML 50 MLS; TOBRAMYCIN/AMPHOTERICIN-B/BUDESONIDE, STERILE 125MG/5MG/0.6MG/5ML NASO-NEB 70 ML (9 DIFFERENT PRODUCTS)
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1627-2012
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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