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Class II: temporary or reversible health riskTerminated

Apothecus Pharmaceutical VCF Vaginal Contraceptive Film Recall

VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single fi…

Apothecus Pharmaceutical Corp. · Hicksville, NY

Risk level
Class II
Reported by FDA
Apr 3, 2024
Recall ID
D-0427-2024
Check your lot numberHow we source this data

Summary

Apothecus Pharmaceutical recalled VCF Vaginal Contraceptive Film starting Mar 21, 2024. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0427-2024 on Apr 3, 2024. Reason: cGMP Diviations. Status: Terminated.

Why it was recalled

cGMP Diviations

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 numbers, UPCs & expiration codes

Lot # 1G008A/1G00804722, Exp 07/31/25

Where it was sold

USA nationwide.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0427-2024
Classification
Class II
Status
Terminated
Recall initiated
Mar 21, 2024
FDA report date
Apr 3, 2024
Quantity
17,280 paper cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Apothecus Pharmaceutical Corp.

Original FDA data

Every field from FDA enforcement report D-0427-2024, exactly as published.

Show all FDA fields
City
Hicksville
State
NY
Status
Terminated
Country
United States
Event ID
94277
Address
485 S Broadway Ste 27
Code information
Lot # 1G008A/1G00804722, Exp 07/31/25
Postal code
11801-5071
Report date
Apr 3, 2024
Product type
Drugs
Recall number
D-0427-2024
Classification
Class II
Recalling firm
Apothecus Pharmaceutical Corp.
Product quantity
17,280 paper cartons
Termination date
Sep 9, 2024
Reason for recall
cGMP Diviations
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
USA nationwide.
Recall initiation date
Mar 21, 2024
Initial firm notification
Letter
Center classification date
Mar 28, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0427-2024, published Apr 3, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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