Recalls / Class II
Class IID-0387-2022
Product
Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50
- Affected 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.
Why it was recalled
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Recalling firm
- Firm
- Mayne Pharma Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1240 Sugg Pkwy, N/A, Greenville, North Carolina 27834-9006
Distribution
- Quantity
- 17,113 canisters
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-01-14
- FDA classified
- 2022-01-19
- Posted by FDA
- 2022-01-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0387-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.