Drug product
Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
D-1045-2013
Product summary
- Firm
- JCB Labs LLC
- Event
- Event 66099
- Status
- Terminated
- Classification
- Class II
- Quantity
- 397 vials
- Official record key
drug-enforcement:D-1045-2013
Official wording
Reason: Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Code information: Lot # 130620@2, Exp 12/17/2013
Distribution pattern: Nationwide and Guam
Derived failure modes
-
Microbial contamination
microbial contamination
-
Sterility assurance
Lack of Assurance of Sterility