MITOMYCIN INJECTION 0.375 mg/mL SYR, 0.375 mg/mL solution, 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave
Summary
The FDA issued a Class II for MITOMYCIN INJECTION 0.375 mg/mL SYR, 0.375 mg/mL solution, 1 mL syringe, Rx only by Pharmacy Plus, Inc. dba Vital Care Compounder. Reason: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the produc.
Details
Source
Drug Recall
External ID
D-0039-2023
Action Date
2022-11-09
Status
Ongoing
Category
drug
Product Description
MITOMYCIN INJECTION 0.375 mg/mL SYR, 0.375 mg/mL solution, 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lot/Code Info: Lots: 60618, BUD: 5/6/2023; 66536, BUD: 7/8/2023
Quantity Affected: 185 syringes
Reason for Recall
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Distribution
AL, LA, MS, and TN
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-07
Company
Hattiesburg, MS
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 59 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Pharmacy Plus, Inc. dba Vital Care Compounder has 33 FDA actions in our database, including 33 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 (Pharmacy Plus, Inc. dba Vital Care Compounder) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pharmacy Plus, Inc. dba Vital Care Compounder have FDA actions?
Pharmacy Plus, Inc. dba Vital Care Compounder has 33 FDA actions in our database, including 33 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0039-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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