The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1044-2013·Announced 2013-09-25

JCB Labs Recalls Sodium Thiosulfate Injection Due to Sterility Concerns

JCB Labs LLC is recalling 1,056 vials of Sodium Thiosulfate 25% injection because laboratory results indicate microbial contamination and sterility cannot be assured.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a sterile injectable product with confirmed microbial contamination, which poses a significant risk of serious injury or hospitalization.

Plain-English summary

JCB Labs LLC is recalling 1,056 vials of Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Injection, 50 mL Single Dose Vial, For Office Use Only. The affected lots are 130701@9 (Exp 12/28/2013), 130709@6 (Exp 01/05/2014), and 130717@2 (Exp 01/13/2014). The product was distributed nationwide and to Guam.

The recall was initiated due to laboratory results from a contract lab indicating microbial contamination. The FDA expressed concern that the test results obtained from the recalling firm's contract testing lab may not be reliable, meaning the sterility of the products cannot be assured.

Healthcare providers and patients should stop using the affected vials and contact JCB Labs LLC for further instructions or returns.

The recalled product

Product
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.
Manufacturer
JCB Labs LLC
Category
Drug — Injectable Solution
Hazard
Affected units
1,056

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot #: 130701@9
  • Exp 12/28/2013
  • 130709@6
  • Exp 01/05/2014
  • 130717@2
  • Exp 01/13/2014

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by JCB Labs LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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