Apothecus Recalls VCF Vaginal Contraceptive Foam Due to Canister Leakage
Apothecus Pharmaceutical Corp. is recalling VCF Vaginal Contraceptive Foam cans and case packs because the canister units exhibit propellant leakage, rendering the product unusable.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The defect renders the product unusable but does not pose a direct safety hazard.
Plain-English summary
Apothecus Pharmaceutical Corp. is recalling VCF Vaginal Contraceptive Foam, including individual cans and case packs, due to a defective delivery system. The canister units are exhibiting propellant leakage or loss, which renders both the product and the canister unusable.
The recall affects Lot # 31560 and 31561 with an expiration date of 06/2021. The affected products were distributed nationwide in the US and Canada. The total quantity involved is 34,417 individual cans and 142 cases containing 5,112 cans.
Consumers should stop using the affected product and return it to the place of purchase for a refund or replacement. This recall is classified as Class III by the FDA, indicating that use of the product is not likely to cause adverse health consequences.
The recalled product
- Product
- 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.
- Manufacturer
- Apothecus Pharmaceutical Corp.
- Category
- Drug — Contraceptive
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 31560
- 31561 exp. date 06/2021
Distribution
Distributed nationwide across the United States.
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