Recall Register

Food, drugs, devices › Ferring Pharmaceuticals Inc

Drug recall: Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal ap

FDA enforcement event 92494 · Class II · initiated 12 Jun 2023 · status Terminated · terminated 5 Aug 2024

DrugN/A1 product recordParsippany, NJ

FDA enforcement event 92494 is a drug recall by Ferring Pharmaceuticals Inc of Parsippany, NJ, initiated 12 Jun 2023 and classified Class II, with 1 product record.

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. 59% of the 281 drug enforcement events initiated in 2023 carry the same class.

Status: Terminated, terminated 5 Aug 2024. Initiation: n/a. Ferring Pharmaceuticals Inc has 9 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

Ferring Pharmaceuticals Inc, Parsippany, NJ.

Reason for recall

"cGMP deviations: potential for Microbial Contamination of Non-Sterile Products"

Distribution

"USA Nationwide"

Product records

Recall numberProductQuantityClassStatusReport date
D-0879-2023Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ NDC# 55566-6500-03N/AClass IITerminated5 Jul 2023

Context

59%of 2023 drug events are Class II281 events that year
1product record in this eventfirm median: 1
9events on this register for the firm

Other enforcement events for Ferring Pharmaceuticals Inc

InitiatedProduct (first record)TypeClassRecords
11 Mar 2021ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx DrugClass II2
2 Mar 2021Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials of Menotropins for injection, 5 single doDrugClass III1
21 Jul 2020DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring Pharmaceuticals Inc., PaDrugClass I3
9 Sep 2015Bravelle 75 IU (urofollitropin for injection, purified) For Subcutaneous or Intramuscular Injection Only, 1 Carton (contDrugClass III1
28 Apr 2014TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel, DistriDrugClass II1
19 Sep 2013ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc.DrugClass III1
1 Feb 2013TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescription Only. Distributed By: TEVA Biologics & SpDrugClass III1
23 Aug 2012Novarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE ONLY Rx Only NDC 55566-1501-0 ManDrugClass III1

All 9 events for Ferring Pharmaceuticals Inc

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "cGMP deviations: potential for Microbial Contamination of Non-Sterile Products"

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 5 Aug 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.