ASP CARES

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0261-2022Class IIBiotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, RNovember 17, 2021
D-0260-2022Class IIMethylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or IV Use OnlyNovember 17, 2021
D-0262-2022Class IIAscorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or SC Use OnlyNovember 17, 2021