Class II
Terminated
Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Free/Sulfite Free, 1-mL Single-Use Syringe, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
This recall has been terminated (originally issued September 25, 2013).
- Company
- Jcb Labs Llc
- Recall Initiated
- August 23, 2013
- Posted
- September 25, 2013
- Recall Number
- D-1047-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1243 Syringes
- Firm Location
- Wichita, KS, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide and Guam
Lot / Code Info
Lot # 130806@2, Expiry 09/20/2013.
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