drugs Class II Updated 2013-09-25

JCB Labs LLC recalls Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile

Recalled Product

Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # 130627@5, Exp 08/26/2013
View official government recall

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