D-1043-2013 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 25, 2013
- Initiation Date
- August 23, 2013
- Termination Date
- August 18, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 903 vials
Product Description
Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
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 Pattern
Nationwide and Guam
Code Information
Lot # 130627@5, Exp 08/26/2013