Vcf Contraceptive Film, Soluble
FDA Recall NDC 52925-112
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 (NDC 52925-112). A significant event, classified as Class II, was initiated on Mar 21, 2024 by Apothecus Pharmaceutical Corp.. The reported reason for this action was: "cGMP Diviations"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
cGMP Diviations
Mar 21, 2024
Apr 03, 2024
17,280 paper cartons
Recall Profile & Regulatory Data
Event ID
94277
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Apothecus Pharmaceutical Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Sep 09, 2024
Product Description
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
Affected Packages Involved in this Recall
52925-112-01Product
52925-112-25Product
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.
