ASP CARES

FDA Regulatory Profile

ASP CARES appears in FDA public data with 3 recalls, 0 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0260-2022, Class II) was initiated on November 17, 2021.

Summary

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

Recent Recalls

NumberClassProductDate
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-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-0262-2022Class IIAscorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or SC Use OnlyNovember 17, 2021