Ferring Pharmaceuticals Inc: Drug Recall

Recall #D-0299-2021 · 03/02/2021

Class III: Low Risk

Recall Details

Recall Number: D-0299-2021
Classification: Class III
Product Type: Drug
Recalling Firm: Ferring Pharmaceuticals Inc
Status: Terminated
Date Initiated: 03/02/2021
Location: Parsippany, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,155,601 cartons/5 vials per carton 12546 physician samples

Reason for Recall

Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP

Product Description

Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials of Menotropins for injection, 5 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL, NDC 55566-7501-2; b) Professional Sample Kit: 3 single dose vials of Menotropins for injection, 3 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL, NDC 55566-7501-3; Rx Only, Manufactured for Ferring Pharmaceuticals Inc. Parsippany. NJ 07054. Diluent manufactured for Ferring Pharmaceuticals Inc.

Distribution Pattern

Distributed nationwide in the USA.

Other Recalls by Ferring Pharmaceuticals Inc

Class II: Risk 06/12/2023

cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Class II: Risk 03/11/2021

Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Class II: Risk 03/11/2021

Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.

View all recalls by Ferring Pharmaceuticals Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.