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.
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 an injectable drug product. A lack of sterility assurance in a parenteral (injectable) preparation poses a risk of serious infection and meets the Severe criterion for Class II recalls with potential for serious adverse health consequences.
Plain-English summary
ASP Cares is recalling Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vials (NDC 72833-565-30) because the manufacturer cannot assure that the product meets sterility requirements.
Lot 082921565 with a beyond-use date of 02/25/2022 is affected. Approximately 1,605 vials were distributed in the United States.
Methylcobalamin is a form of vitamin B12 administered by injection. A lack of sterility assurance means the product may be contaminated with bacteria, fungi, or other microorganisms that could cause serious infection if injected.
If you have received this product, do not use it. Contact your healthcare provider or pharmacist for guidance on safe alternatives. Return the product to your pharmacy or healthcare provider.
The recalled product
- 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
- Manufacturer
- ASP CARES
- Category
- Drug — Injectable
- Affected units
- 1,605
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: 082921565 BUD: 02/25/2022
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.
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