Hicksville, NY, United States
Apothecus Pharmaceutical Corp. recalls
3 recalls recorded since 2018, most recently on 22 November 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 22 November 2024
- Reason
- CGMP deviations: out of specifications for assay
- Distribution
- Nationwide in the USA and 2 Distributors in Hong Kong
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0151-2025
- 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
Terminated Class II Drugs
- Recall started
- 21 March 2024
- Terminated
- 9 September 2024
- Reason
- cGMP Diviations
- Distribution
- USA nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0427-2024
- VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01
Terminated Class III Drugs
- Recall started
- 25 November 2019
- Terminated
- 24 September 2024
- Reason
- Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable
- Distribution
- Nationwide in the US and Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0623-2020
- 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: Apo
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.