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.
Product description
Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Injection, 50 mL Single Dose Vial, For Office Use Only, JCB Laboratories, Wichita, KS.
Lot numbers, UPCs & expiration codes
Lot #: 130701@9, Exp 12/28/2013; 130709@6, Exp 01/05/2014; 130717@2, Exp 01/13/2014
Where it was sold
Nationwide and Guam
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1044-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 23, 2013
- FDA report date
- Sep 25, 2013
- Quantity
- 1056 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- JCB Labs LLC
Original FDA data
Every field from FDA enforcement report D-1044-2013, exactly as published.
Show all FDA fields
- City
- Wichita
- State
- KS
- Status
- Terminated
- Country
- United States
- Event ID
- 66099
- Address
- 7335 W 33rd St N
- Code information
- Lot #: 130701@9, Exp 12/28/2013; 130709@6, Exp 01/05/2014; 130717@2, Exp 01/13/2014
- Postal code
- 67205-9368
- Report date
- Sep 25, 2013
- Product type
- Drugs
- Recall number
- D-1044-2013
- Classification
- Class II
- Recalling firm
- JCB Labs LLC
- Product quantity
- 1056 vials
- Termination date
- Aug 18, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Injection, 50 mL Single Dose Vial, For Office Use Only, JCB Laboratories, Wichita, KS.
- Distribution pattern
- Nationwide and Guam
- Recall initiation date
- Aug 23, 2013
- Initial firm notification
- Telephone
- Center classification date
- Sep 13, 2013