Class II · Moderate risk
Tobramycin for Injection
Failed Stability Specification: Water determination was found not complying with specification.
Tobramycin 620 mg/NS 100 mL Accuflo
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Tobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drug: Tobramycin
- Recalling firm
- Walgreens Infusion Services
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0553-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 Walgreens Infusion Services
All 2015 recalls
Class II · Moderate risk
3-in-1 TPN formula daily+overfill Bag
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride/MVI injection 2000 mL Bag
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride injection bag
Lack of Assurance of Sterility
Class II · Moderate risk
Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL
Lack of Assurance of Sterility
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