Apothecus Pharmaceutical Corp. recalls 10 pre-filled VCF vaginal contraceptive gel applicators due to CGMP deviations causing out-of-specification assay results. No remedy specified in official notice.
CGMP deviations: out of specifications for assay
Apothecus Pharmaceutical Corp. is recalling 10 pre-filled VCF vaginal contraceptive gel applicators because they failed quality tests. This could mean the product doesn't work as intended, but the recall doesn't specify a risk of injury or illness.
The product failed quality tests for assay accuracy, meaning the gel might not provide the intended contraceptive effect. This could lead to unintended pregnancy if used as intended, but the recall does not mention any risk of injury or illness.
Women who purchased the VCF vaginal contraceptive gel applicators from Apothecus Pharmaceutical Corp. in the U.S. are likely affected. Those with medical conditions requiring precise hormone levels may be at slightly higher risk.
Check for the product name 'VCF Vaginal Contraceptive Gel' with 10 pre-filled applicators. Look for the lot number 3A001/3A001A and expiration date of 07/25 on the packaging.
Verify the product name, lot number, and expiration date on the packaging to confirm if it's recalled.
The recall does not mention any risk of injury or illness, only that the product failed quality tests.
The official notice does not specify a remedy, so check the product details to confirm if it's recalled.
Look for the lot number 3A001/3A001A and expiration date of 07/25 on the packaging.
We’ve drafted a message you can send Apothecus to request your refund or repair — edit it as you like.
Subject: Recall D-0151-2025 — Apothecus Apothecus Hello, I own a Apothecus that is covered by recall D-0151-2025 from Apothecus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.