Mayne Pharma Inc

FDA Regulatory Profile

Mayne Pharma Inc appears in FDA public data with 6 recalls, 0 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (D-1152-2022, Class II) was initiated on June 9, 2022.

Summary

Total Recalls
6
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1152-2022Class IIClonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04June 9, 2022
D-0387-2022Class IILexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: MayneJanuary 14, 2022
D-0998-2020Class IICarbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NMarch 2, 2020
D-1129-2018Class IIIOxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: August 21, 2018
D-0616-2018Class IIIFabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NCMarch 21, 2018
D-0098-2018Class IILiothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo MinneapNovember 9, 2017