RecallDepth
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.

Other recent Class II Drug recalls