VCF Vaginal Contraceptive Film
cGMP Diviations
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP deviations: out of specifications for assay
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
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
Compare with the code on your package — it is the most precise check available.
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 Pre-Filled Applicators Nonoxynol-9 NDC 52925-0512 |
4 g/100g | Gel, Metered Vaginal |
Apothecus Pharmaceutical CORP | OTC |
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.
cGMP Diviations
Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
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