Vcf Contraceptive Pre-filled Applicators Gel, Metered
FDA Recall NDC 52925-512
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Vcf Contraceptive Pre-filled Applicators (NDC 52925-512). A significant event, classified as Class II, was initiated on Nov 22, 2024 by Apothecus Pharmaceutical Corp. The reported reason for this action was: "CGMP deviations: out of specifications for assay"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP deviations: out of specifications for assay
Nov 22, 2024
Dec 25, 2024
33,659 retail boxes in US
Recall Profile & Regulatory Data
Event ID
95824
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Apothecus Pharmaceutical Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and 2 Distributors in Hong Kong
Product Description
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
Affected Packages Involved in this Recall
52925-512-10Product
52925-512-25Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
