Recall

Could cause harm

VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09…

CGMP deviations: out of specifications for assay

Official FDA data record

What to do

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  1. 1Compare the product, size and lot or date code with this notice.
  2. 2If your product matches, stop using it and follow the official recall instructions.
  3. 3Read the official notice for return, refund or disposal instructions.

What the notice says

CGMP deviations: out of specifications for assay. This could cause temporary or reversible health problems.

Recall details

Firm
Apothecus Pharmaceutical Corp.
Status
Ongoing
Reported
Dec 25, 2024
Started
Nov 22, 2024
Where sold
Nationwide in the USA and 2 Distributors in Hong Kong
Quantity
33,659 retail boxes in US
Notice number
D-0151-2025

Lots, UPC, dates

Lot: 3A001/3A001A, Exp: 07/25

Agency wording

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

Source: FDA OTC report. This is not medical advice. Compare your package codes before you act.