Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville,
Summary
The FDA issued a Class II for Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, D by Mayne Pharma Inc. Reason: CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam..
Details
Source
Drug Recall
External ID
D-0387-2022
Action Date
2022-01-26
Status
Ongoing
Category
drug
Product Description
Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50
Lot/Code Info: Lot #: 32451 Exp. 03/2022; 32532 Exp. 04/2022; 32552 Exp. 05/2022; 32701 32733 Exp. 10/2022; 32855 Exp. 02/2023; 32872 Exp. 03/2023.
Quantity Affected: 17,113 canisters
Reason for Recall
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-14
Company
Greenville, NC
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.
Mayne Pharma Inc 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 (Mayne Pharma Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mayne Pharma Inc have FDA actions?
Mayne Pharma Inc 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-0387-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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