Medications & Supplements/Prescription Drugs

ASP CARES Injectable Solutions Recalled for Lack of Sterility Assurance

Agency Publication Date: November 26, 2021

Summary

ASP CARES has recalled 5,578 vials of Methylcobalamin, Biotin, and Ascorbic Acid (Vitamin C) injectable solutions because they may not be sterile. Using an injectable product that is not sterile can lead to serious, potentially life-threatening infections at the injection site or in the bloodstream. These medications were sold in 30 mL and 50 mL multiple-dose vials and were distributed across the United States. While no injuries have been reported to date, the manufacturer is initiating this recall as a precaution to ensure patient safety.

Risk

Injecting a product that lacks assurance of sterility can introduce bacteria or other contaminants directly into the body, bypassing natural defenses. This poses a significant risk of localized infections or systemic illness, such as sepsis, which can be fatal if not treated promptly.

What You Should Do

The recalled products include ASP CARES Methylcobalamin (1 mg/mL, 30 mL), Biotin (10 mg/mL, 30 mL), and Ascorbic Acid (500 mg/mL, 50 mL) injectable solutions in multiple-dose vials.
Identify affected vials by checking the lot numbers and expiration dates: Methylcobalamin (lot 082921565, BUD 02/25/2022), Biotin (lot 091721589, BUD 03/16/2022), and Ascorbic Acid (lots 092321690, BUD 03/22/2022 and 093021690, BUD 03/29/2022).
Stop using the recalled injectable solutions immediately to avoid the risk of infection.
Contact the manufacturer, ASP CARES, or your distributor to arrange for the return of any remaining vials.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information or to report any adverse effects.

Your Remedy Options

Other Action

Inventory retrieval and return

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Methylcobalamin Solution for Injection (1 mg/mL, 30 mL)

Variants: Multiple Dose Vial, For IM, SC or IV Use Only

Lot Numbers:

082921565 (Exp 02/25/2022)

NDC:

72833-565-30

Recall #: D-0260-2022; Distributed Quantity: 1605 vials

Product: Biotin Solution for Injection (10 mg/mL, 30 mL)

Variants: Multiple Dose Vial, Sterile, For IM or IV use only

Lot Numbers:

091721589 (Exp 03/16/2022)

NDC:

72833-0589-30

Recall #: D-0261-2022; Distributed Quantity: 896 vials

Product: Ascorbic Acid Solution for Injection (500 mg/mL, 50 mL)

Variants: Multiple Dose Vial, For IM, IV or SC Use Only

Lot Numbers:

092321690 (Exp 03/22/2022)

093021690 (Exp 03/29/2022)

NDC:

72833-690-50

Recall #: D-0262-2022; Distributed Quantity: 3077 vials

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89076

Status: Resolved

Manufacturer: ASP CARES

Sold By: ASP CARES

Manufactured In: United States

Units Affected: 3 products (1605 vials; 896 vials; 3077 vials)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

The recalled products include ASP CARES Methylcobalamin (1 mg/mL, 30 mL), Biotin (10 mg/mL, 30 mL), and Ascorbic Acid (500 mg/mL, 50 mL) injectable solutions in multiple-dose vials.

Identify affected vials by checking the lot numbers and expiration dates: Methylcobalamin (lot 082921565, BUD 02/25/2022), Biotin (lot 091721589, BUD 03/16/2022), and Ascorbic Acid (lots 092321690, BUD 03/22/2022 and 093021690, BUD 03/29/2022).

Stop using the recalled injectable solutions immediately to avoid the risk of infection.

Contact the manufacturer, ASP CARES, or your distributor to arrange for the return of any remaining vials.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information or to report any adverse effects.

Affected Products

Product: Methylcobalamin Solution for Injection (1 mg/mL, 30 mL)

Variants: Multiple Dose Vial, For IM, SC or IV Use Only

Lot Numbers:

082921565 (Exp 02/25/2022)

NDC:

72833-565-30

Recall #: D-0260-2022; Distributed Quantity: 1605 vials

Product: Biotin Solution for Injection (10 mg/mL, 30 mL)

Variants: Multiple Dose Vial, Sterile, For IM or IV use only

Lot Numbers:

091721589 (Exp 03/16/2022)

NDC:

72833-0589-30

Recall #: D-0261-2022; Distributed Quantity: 896 vials

Product: Ascorbic Acid Solution for Injection (500 mg/mL, 50 mL)

Variants: Multiple Dose Vial, For IM, IV or SC Use Only

Lot Numbers:

092321690 (Exp 03/22/2022)

093021690 (Exp 03/29/2022)

NDC:

72833-690-50

Recall #: D-0262-2022; Distributed Quantity: 3077 vials