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Recall Observatory FDA recall evidence

Drug product

Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50

D-0387-2022

January 14, 2022

Class II

Product summary

Firm
Mayne Pharma Inc
Event
Event 89397
Status
Ongoing
Classification
Class II
Quantity
17,113 canisters
Official record key
drug-enforcement:D-0387-2022

Official wording

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

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.

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviation