Apothecus Pharmaceutical Corp.

FDA Regulatory Profile

Apothecus Pharmaceutical Corp. appears in FDA public data with 3 recalls, 1 510(k) clearance, 8 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0151-2025, Class II) was initiated on November 22, 2024. Its most recent 510(k) clearance was granted on March 9, 2001.

Summary

Total Recalls
3
510(k) Clearances
1
Inspections
8
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0151-2025Class IIVCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) EaNovember 22, 2024
D-0427-2024Class IIVCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, DistribuMarch 21, 2024
D-0623-2020Class IIIVCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g). NDC 52925-312November 25, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K010182VCF PERSONAL LUBRICANTMarch 9, 2001