Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only...
FDA Recall #D-0261-2022 — Class II — November 17, 2021
Product Description
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
Recalling Firm
ASP CARES — San Antonio, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
896 vials
Distribution
United States
Code Information
Lot: 091721589 BUD: 03/16/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated