Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx o
Summary
The FDA issued a Class II for Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), a by Ingenus Pharmaceuticals Llc. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0374-2022
Action Date
2022-01-26
Status
Terminated
Category
drug
Product Description
Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.
Lot/Code Info: a) Lots: 32921 Exp. 06/2022; 33152 Exp. 08/2022; 33340 Exp. 11/2022; b) Lots: 33152 Exp. 08/2022; 33340 Exp. 11/2022.
Quantity Affected: 45,173 cans
Reason for Recall
CGMP Deviations
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-10
Company
Orlando, FL
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 44 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Ingenus Pharmaceuticals 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 (Ingenus Pharmaceuticals Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ingenus Pharmaceuticals Llc have FDA actions?
Ingenus Pharmaceuticals 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-0374-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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