FDA Recall D-0387-2022

Mayne Pharma Inc · Greenville, NC

Class II Ongoing 1581 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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: 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: 17,113 canisters

Reason for recall

CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.

Recall record

Recall number: D-0387-2022
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2022-01-14
Classified by FDA Center: 2022-01-19
FDA published: 2022-01-26
Recalling firm: Mayne Pharma Inc
Firm location: Greenville, NC

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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