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Recall Observatory FDA recall evidence

Drug 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.

D-1043-2013

August 23, 2013

Class II

Product summary

Firm
JCB Labs LLC
Event
Event 66099
Status
Terminated
Classification
Class II
Quantity
903 vials
Official record key
drug-enforcement:D-1043-2013

Official wording

Reason: 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.

Code information: Lot # 130627@5, Exp 08/26/2013

Distribution pattern: Nationwide and Guam

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    microbial contamination
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility