TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Cree
Summary
The FDA issued a Class II for TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx o by Carolina Infusion. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-1523-2022
Action Date
2022-09-21
Status
Completed
Category
drug
Product Description
TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lot/Code Info: Lots: 07182022@9 BUD: 10/16/2022; 07272022@15 BUD: 10/25/2022
Quantity Affected: 3 vials
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-26
Company
Ridgeland, SC
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 76 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Carolina Infusion has 20 FDA actions in our database, including 20 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 (Carolina Infusion) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Carolina Infusion have FDA actions?
Carolina Infusion has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1523-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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