Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentow
Summary
The FDA issued a Class II for Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulat by US Specialty Formulations LLC. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0986-2022
Action Date
2022-06-15
Status
Terminated
Category
drug
Product Description
Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229
Lot/Code Info: Lot #: 02RP1503A, exp. date 30-Sep-22; 02RP1506A, exp. date 31-Dec-22; 02RP1516A, exp. date 30-Jun-23
Quantity Affected: 781 vials
Reason for Recall
Lack of Assurance of Sterility
Distribution
Product was distributed to medical facilities and a physician's office Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-24
Company
Allentown, PA
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 180 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
US Specialty Formulations LLC has 2 FDA actions in our database, including 2 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 (US Specialty Formulations LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does US Specialty Formulations LLC have FDA actions?
US Specialty Formulations LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0986-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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