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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
See all 5 products in this recall →Related recalls
Same manufacturer · JCB Labs LLC
See all →- SevereJCB Labs Recalls Sodium Thiosulfate Injection Due to Sterility Concerns
FDA (Drugs) · 2013-09-25
- SevereJCB Labs Recalls Acetylcysteine Solution Due to Sterility Concerns
FDA (Drugs) · 2013-09-25
- SevereJCB Labs Recalls Sodium Citrate Injection Due to Sterility Concerns
FDA (Drugs) · 2013-09-25
- SevereJCB Labs Recalls Epinephrine Syringes Due to Sterility Concerns
FDA (Drugs) · 2013-09-25
Same hazard · microbial contamination
See all →- CriticalVictory Medical Center Pharmacy Recalls Glutathione Vials Due to Contamination
FDA (Drugs) · 2026-08-19
- HighMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15