VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Ph
Summary
The FDA issued a Class II for VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 si by Apothecus Pharmaceutical Corp.. Reason: cGMP Diviations.
Details
Source
Drug Recall
External ID
D-0427-2024
Action Date
2024-04-03
Status
Terminated
Category
drug
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
Lot/Code Info: Lot # 1G008A/1G00804722, Exp 07/31/25
Quantity Affected: 17,280 paper cartons
Reason for Recall
cGMP Diviations
Distribution
USA nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-21
Company
Hicksville, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 69 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Apothecus Pharmaceutical Corp. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Apothecus Pharmaceutical Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Apothecus Pharmaceutical Corp. have FDA actions?
Apothecus Pharmaceutical Corp. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0427-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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