JCB Labs LLC

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1047-2013Class IIEpinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Free/Sulfite Free, 1-mL SiAugust 23, 2013
D-1046-2013Class IISodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for Office Use OnlAugust 23, 2013
D-1044-2013Class IISodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Injection, 50 mL Single DosAugust 23, 2013
D-1043-2013Class IIAcetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, StAugust 23, 2013
D-1045-2013Class IISodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 30 mL Multi Dose Vial, SAugust 23, 2013