The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0261-2022·Announced 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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall is classified as FDA Class II. The hazard involves lack of sterility assurance in an injectable drug product administered directly into the body, which poses a significant potential for serious adverse outcomes including infection and sepsis. Although no illnesses or injuries are reported in the source text, the nature of the hazard and the product classification meet the criteria for a Severe rating.

Plain-English summary

ASP CARES is recalling Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only (NDC 72833-0589-30) due to lack of assurance of sterility.

The recalled product consists of 896 vials from Lot 091721589, with a beyond-use date of 03/16/2022. The product was distributed throughout the United States.

Because the sterility of this injectable medication cannot be assured, there is a potential risk to patients who receive it. Sterility is a critical requirement for injectable products. Healthcare providers and patients who have received this product should contact their healthcare provider for guidance. The product should not be used.

For additional information, consumers and healthcare providers may contact ASP CARES at 2414 Babcock Rd Ste #106, San Antonio, TX 78229.

The recalled product

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
Manufacturer
ASP CARES
Category
Drug — Injectable / Vitamin
Hazard
Affected units
896

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: 091721589 BUD: 03/16/2022

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by ASP CARES under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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