FDA recall D-0261-2022

ASP CARES · Class II · drug

Product

Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-0589-30

Reason for recall

Lack of Assurance of Sterility

Distribution

United States

Key facts

Status
Terminated
Initiation date
2021-11-17
Report date
2021-12-08
Termination date
2022-12-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Antonio, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0261-2022