D-0387-2022 Class II Ongoing
FDA drug recall D-0387-2022 was initiated by Mayne Pharma Inc on Jan 14, 2022 and is designated Class II. Reason for recall: CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam. The recall status is ongoing. Affected quantity: 17,113 canisters.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 26, 2022
- Initiation Date
- Jan 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,113 canisters
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
Reason for Recall
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Distribution Pattern
Nationwide within the United States
Code Information
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0387-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026