March 2024 FDA Recall Vcf Contraceptive by Apothecus Pharmaceutical Corp.
D-0427-2024 - cGMP Diviations
This Class II drug recall was voluntarily initiated by Apothecus Pharmaceutical Corp. on March 21, 2024 for the product Vcf Contraceptive. The FDA reported the reason for recall as cgmp diviations. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0427-2024
cGMP Diviations
03-21-2024
04-03-2024
17,280 paper cartons
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.
Terminated
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.
USA nationwide.
09-09-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01
Batch or Lot Expiration Information
Lot# 1G008A/1G00804722, Exp 07/31/25
