Class II · Moderate risk
VCF, Vaginal Contraceptive Gel
CGMP deviations: out of specifications for assay
VCF Vaginal Contraceptive Film (Nonoxynol-9)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Diviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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
Affected NDC
52925-0112-01
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Vcf Contraceptive Nonoxynol-9 NDC 52925-0112 |
280 mg/1 | Film, Soluble Vaginal |
Apothecus Pharmaceutical CORP. | OTC |
- Recalling firm
- Apothecus Pharmaceutical Corp.
- NDC code
- 52925-112-01
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0427-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Apothecus Pharmaceutical Corp.
All 2024 recalls
Class III · Low risk
VCF Vaginal Contraceptive Foam
Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable
Other cgmp deviation recalls from 2024
All cgmp deviation recalls
Class II · Moderate risk
First Aid Beauty Ultra Repair Cream
CGMP Deviations; product intended for quarantine was inadvertently distributed
Class II · Moderate risk
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CGMP Deviations
Class II · Moderate risk
10 Irregular Pigmentation
CGMP Deviations: Inconsistency in the water systems.
Class II · Moderate risk
Henry Schein
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
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