JCB Labs Recalls Sodium Citrate Injection Due to Sterility Concerns
JCB Labs LLC is recalling 397 vials of Sodium Citrate 4% with Gentamicin due to potential microbial contamination and unreliable sterility test results.
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 risk of microbial contamination in a sterile injectable product, which aligns with the rubric criteria for Severe severity involving significant injury risks or Class II classifications with potential for serious harm.
Plain-English summary
JCB Labs LLC is recalling 397 vials of Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 30 mL Multi Dose Vial. The product is a sterile solution intended for office use only. The recall covers Lot # 130620@2, with an expiration date of 12/17/2013.
The recall was initiated because laboratory results from a contract lab indicated 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.
The affected product was distributed nationwide and in Guam. Consumers and healthcare providers should stop using the product and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- Sodium Citrate 4% containing Gentamicin 320 mcg/mL, 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
- 397
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 # 130620@2
- Exp 12/17/2013
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 Epinephrine Syringes Due to Sterility Concerns
FDA (Drugs) · 2013-09-25
- SevereJCB Labs Recalls Sodium Citrate Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2013-09-25
Same hazard · microbial contamination
See all →- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- CriticalOptimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
FDA (Drugs) · 2026-09-09
Similar recalls
- SevereKRS Global Biotechnology Recalls Sodium Citrate and Gentamicin Vials
FDA (Drugs) · 2019-10-09
- HighFDA Recalls Sodium Citrate Injectable Solution Due to Sterility Concerns
FDA (Drugs) · 2024-04-03
- SevereSCA Pharmaceuticals Recalls Sodium Citrate Syringes Due to Sterility Concerns
FDA (Drugs) · 2021-01-13
- SeverePharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- HighInjectable Fentanyl Vials Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2024-04-10
- SevereSCA Pharmaceuticals Recalls Ketamine Injection Due to Sterility Concerns
FDA (Drugs) · 2019-08-28