Status
Terminated
Drug Enforcement D-1045-2013
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.
Classification
Class II
Report Date
September 25, 2013
Termination Date
August 18, 2014
Product Information
- Product description
- 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.
- Product quantity
- 397 vials
- Reason for recall
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Nationwide and Guam
Location & Firm
- Recalling firm
- JCB Labs LLC
- Address
-
7335 W 33rd St N, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1045-2013
- Event ID
- 66099
- Recall initiation date
- August 23, 2013
- Center classification date
- September 13, 2013
- Code info
- Lot # 130620@2, Exp 12/17/2013
- More code info
- —