JCB Labs Recalls Sodium Citrate Injection Vials Due to Sterility Concerns
JCB Labs LLC is recalling 677 vials of Sodium Citrate 4% Solution for 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 microbial contamination of a sterile injectable product, which poses a significant risk of serious injury or death if administered.
Plain-English summary
JCB Labs LLC is recalling 677 vials of Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for Office Use Only. The affected product is identified by Lot # 130710@4 with an expiration date of 01/06/2014. The recall covers distribution nationwide and in Guam.
The recall was initiated due to laboratory results from a contract lab indicating microbial contamination. The FDA expressed concern that test results obtained from the recalling firm's contract testing lab may not be reliable, meaning the sterility of the products cannot be assured.
Consumers and healthcare providers should stop using the affected vials and contact JCB Labs LLC for further instructions or a return.
The recalled product
- Product
- Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for Office Use Only, JCB Laboratories, Wichita, KS.
- Manufacturer
- JCB Labs LLC
- Category
- Drug — Injectable Solution
- Affected units
- 677
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 (2)
- Lot # 130710@4
- Exp. 01/06/2014
Distribution
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.
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