The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0262-2022·Announced 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.

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 is an FDA Class II recall of a sterile injectable drug. Lack of sterility assurance in parenteral products poses a significant risk of microbial contamination and serious infection, meeting the threshold for Severe classification even without reported illnesses.

Plain-English summary

ASP CARES is recalling Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vials (NDC 72833-690-50) because the manufacturer lacks adequate assurance of sterility for the product. The affected lots are 092321690 (BUD 03/22/2022) and 093021690 (BUD 03/29/2022), totaling 3,077 vials distributed throughout the United States.

Ascorbic acid injection is a prescription medication administered by intramuscular, intravenous, or subcutaneous injection. When a sterile injectable product cannot be assured to meet sterility standards, there is a risk that the product could be contaminated with microorganisms, potentially causing serious infections in patients who receive it.

Consumers and healthcare providers who have received this product should contact their healthcare provider or pharmacist. Retailers and wholesalers should immediately stop distribution and return or destroy any remaining product from the affected lots.

The recalled product

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
Manufacturer
ASP CARES
Category
Drug — Injectable / Parenteral
Hazard
Affected units
3,077

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 (2)

  • Lots: 092321690 BUD: 03/22/2022
  • 093021690 BUD: 03/29/2022

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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