VCF Contraceptive Pre-filled Applicators Recalled for Out-of-Specification Active Ingredient
Apothecus Pharmaceutical recalls 33,659 boxes of VCF nonoxynol-9 contraceptive gel nationwide due to out-of-specification active ingredient assay from manufacturing deviations. No illnesses reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a contraceptive product with out-of-specification active ingredient assay due to manufacturing deviations. This qualifies as a risk-of-harm product where efficacy or safety could be compromised; however, no illnesses or injuries have been reported.
Plain-English summary
Apothecus Pharmaceutical Corp. has recalled VCF Contraceptive Pre-filled Applicators (nonoxynol-9) nationwide due to Current Good Manufacturing Practice (CGMP) deviations that resulted in out-of-specification active ingredient assay. The recall affects 33,659 retail boxes in the United States and 2 distributors in Hong Kong. Affected products are Lot 3A001 and 3A001A with expiration date 07/25.
The vaginal contraceptive gel did not meet specifications for the active ingredient (nonoxynol-9) concentration, which could affect product efficacy or safety. Out-of-specification assay indicates the active ingredient levels are outside acceptable manufacturing ranges.
Consumers who have purchased VCF Contraceptive Pre-filled Applicators with Lot 3A001 or 3A001A (expiration 07/25) should discontinue use and consult their healthcare provider or contact Apothecus Pharmaceutical Corp. The FDA has not received reports of adverse events associated with this recall.
The recalled product
- Product
- VCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9)
- Brand
- VCF CONTRACEPTIVE PRE-FILLED APPLICATORS
- Manufacturer
- Apothecus Pharmaceutical Corp.
- Category
- Drug — Contraceptive
- Hazard
- assay-defect
- efficacy-risk
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: 3A001/3A001A
- Exp: 07/25
Distribution
Distributed nationwide across the United States.
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