Why it was recalled
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
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 numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0387-2022
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 14, 2022
- FDA report date
- Jan 26, 2022
- Quantity
- 17,113 canisters
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mayne Pharma Inc
Original FDA data
Every field from FDA enforcement report D-0387-2022, exactly as published.
Show all FDA fields
- City
- Greenville
- State
- NC
- Status
- Ongoing
- Country
- United States
- Event ID
- 89397
- Address
- 1240 Sugg Pkwy
- 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.
- Postal code
- 27834-9006
- Report date
- Jan 26, 2022
- Product type
- Drugs
- Recall number
- D-0387-2022
- Classification
- Class II
- Recalling firm
- Mayne Pharma Inc
- Product quantity
- 17,113 canisters
- Reason for recall
- CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jan 14, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 19, 2022