Recalls / Class II
Class IID-1043-2013
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.
- Affected lot / code info
- Lot # 130627@5, Exp 08/26/2013
Why it was recalled
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.
Recalling firm
- Firm
- JCB Labs LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 7335 W 33rd St N, N/A, Wichita, Kansas 67205-9368
Distribution
- Quantity
- 903 vials
- Distribution pattern
- Nationwide and Guam
Timeline
- Recall initiated
- 2013-08-23
- FDA classified
- 2013-09-13
- Posted by FDA
- 2013-09-25
- Terminated
- 2014-08-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1043-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.