JCB Labs recalls
FDA enforcement reports naming JCB Labs LLC as the recalling firm.
- Recall reports
- 5
- Class I (serious)
- 0
- Most recent report
- Sep 25, 2013
- Sep 25, 2013Sodium Thiosulfate 25%, 250 mg/mL (12Drug · JCB Labs LLCLack 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…Class II
- Sep 25, 2013Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for…Drug · JCB Labs LLCLack 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…Class II
- Sep 25, 2013Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for O…Drug · JCB Labs LLCLack 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…Class II
- Sep 25, 2013Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 30 mL Multi…Drug · JCB Labs LLCLack 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…Class II
- Sep 25, 2013Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Free/Sulfite…Drug · JCB Labs LLCLack 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…Class II