Class II · Moderate risk
VCF, Vaginal Contraceptive Gel
CGMP deviations: out of specifications for assay
VCF Vaginal Contraceptive Foam
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g). NDC 52925-312-14, b) case pack with 36 cans in a nested container. Net wt 0.6 oz (17g) per can. NDC 52925-312-06, Distributed By: Apothecus Pharmaceutical Corp. Oyster Bay, NY 11771.
Affected NDCs
52925-0312-06
52925-0312-14
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Apothecus Pharmaceutical Corp.
- NDC code
- 52925-312-14
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0623-2020 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 2019 recalls
Class II · Moderate risk
VCF Vaginal Contraceptive Film
cGMP Diviations
Other packaging defect recalls from 2019
All packaging defect recalls
Class III · Low risk
Clobetasol Propionate Foam
Defective delivery system; product is not foaming or is coming out as liquid.
Class III · Low risk
Clobetasol Propionate Foam
Defective delivery system; product is not foaming or is coming out as liquid.
Class II · Moderate risk
Estradiol Vaginal Inserts USP
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Class I · High risk
Natpara (parathyroid hormone)
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
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