The Recall Desk

FDA (Drugs) recall action 89076

ASP CARES recalled 3 products on 2021-12-08

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2021-12-08
Critical
0
Units
5,578

Why these products were recalled

Lack of Assurance of Sterility

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • SevereFDA (Drugs)··2021-12-08

    Biotin Solution for Injection recalled due to lack of sterility assurance

    ASP CARES is recalling Biotin Solution for Injection (10 mg/mL, 30 mL vials) because the manufacturer cannot assure the product's sterility. The affected lot was distributed in the United States.

    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
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-12-08

    Methylcobalamin Solution for Injection Recalled for Sterility Risk

    ASP Cares is recalling Methylcobalamin Solution for Injection due to lack of assurance of sterility. The recall affects one lot distributed in the United States.

    Product
    Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or IV Use Only, Rx only, ASP Cares2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-565-30
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-12-08

    Ascorbic Acid Injection Recalled Due to Lack of Sterility Assurance

    ASP CARES is recalling Ascorbic Acid Solution for Injection (500 mg/mL, 50 mL vials) distributed in the United States because the manufacturer cannot assure the product meets sterility requirements.

    Product
    Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or SC Use Only, Rx only, ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-690-50
    Category
    Distribution
    0 states