November 2019 FDA Recall Drug by Apothecus Pharmaceutical Corp.
D-0623-2020 - Defective Delivery System

This Class III drug recall was voluntarily initiated by Apothecus Pharmaceutical Corp. on November 25, 2019 for the product Drug. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0623-2020

Reason for Recall
Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable
Initiated
11-25-2019
Reported
12-25-2019
Quantity
a) 34,417 cans b)142 cases 5,112 cans

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84289
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-24-2024
Product Description About Product Description
Full technical description of the product.
VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g). NDC 52925-312-14, b) case pack with 36 cans in a nested container. Net wt 0.6 oz (17g) per can. NDC 52925-312-06, Distributed By: Apothecus Pharmaceutical Corp. Oyster Bay, NY 11771.

Batch or Lot Expiration Information

Lot# 31560, 31561 exp. date 06/2021