Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or IV Use Only, Rx only, ASP Cares
Summary
The FDA issued a Class II for Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For I by ASP CARES. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0260-2022
Action Date
2021-12-08
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot: 082921565 BUD: 02/25/2022
Quantity Affected: 1605 vials
Reason for Recall
Lack of Assurance of Sterility
Distribution
United States
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-17
Company
San Antonio, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 18 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
ASP CARES has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ASP CARES) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ASP CARES have FDA actions?
ASP CARES has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0260-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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