FDA-Drug2013-09-25Class II
Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
JCB Labs LLC
Hazard
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.
Sold states
Nationwide and Guam
Affected count
903 vials
Manufactured in
7335 W 33rd St N, N/A, Wichita, KS, United States
Products
Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1043-2013Don't want to check this manually?
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