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VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g)...

FDA Recall #D-0151-2025 — Class II — November 22, 2024

Recall #D-0151-2025 Date: November 22, 2024 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

CGMP deviations: out of specifications for assay

Recalling Firm

Apothecus Pharmaceutical Corp. — Hicksville, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

33,659 retail boxes in US

Distribution

Nationwide in the USA and 2 Distributors in Hong Kong

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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