Food, drugs, devices › Apothecus Pharmaceutical Corp.
Drug recall: VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Ph
Apothecus Pharmaceutical Corp. (Hicksville, NY) initiated this drug recall on 21 Mar 2024; FDA lists 1 product record under event 94277, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 71% of the 319 drug enforcement events initiated in 2024 carry the same class.
Status: Terminated, terminated 9 Sep 2024. Initiation: voluntary: firm initiated. Apothecus Pharmaceutical Corp. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Apothecus Pharmaceutical Corp., Hicksville, NY.
Reason for recall
"cGMP Diviations"
Distribution
"USA nationwide."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 | 17,280 paper cartons | Class II | Terminated | 3 Apr 2024 |
Context
Other enforcement events for Apothecus Pharmaceutical Corp.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 22 Nov 2024 | VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: | Drug | Class II | 1 |
| 25 Nov 2019 | VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g). NDC 52925-312-14, b) case pack wi | Drug | Class III | 1 |
All 3 events for Apothecus Pharmaceutical Corp.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "cGMP Diviations"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "USA nationwide."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Sep 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.