November 2024 FDA Recall Vcf Contraceptive Pre-filled Applicators by Apothecus Pharmaceutical Corp.
D-0151-2025 - CGMP deviations
This Class II drug recall was voluntarily initiated by Apothecus Pharmaceutical Corp. on November 22, 2024 for the product Vcf Contraceptive Pre-filled Applicators. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0151-2025
CGMP deviations: out of specifications for assay
11-22-2024
12-25-2024
33,659 retail boxes in US
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Apothecus Pharmaceutical Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA and 2 Distributors in Hong Kong
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmaceutical Corp., Ronkonkoma, NY 11779, NDC 52925-512-10
Batch or Lot Expiration Information
Lot# Lot: 3A001/3A001A, Exp: 07/25
