March 2021 FDA Recall Menopur by Ferring Pharmaceuticals Inc
D-0299-2021 - Failed pH specifications

This Class III drug recall was voluntarily initiated by Ferring Pharmaceuticals Inc on March 2, 2021 for the product Menopur. The FDA reported the reason for recall as failed ph specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0299-2021

Reason for Recall
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Initiated
03-02-2021
Reported
03-17-2021
Quantity
1,155,601 cartons/5 vials per carton 12546 physician samples

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87382
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ferring Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2022
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# Lots# a) P12585AC, Exp. Date 31-Mar-2020 P12677AA, Exp. Date 31-Mar-2020 P12678AA, Exp. Date 31-Jul-2020 P12679AA, Exp. Date 31-Jul-2020 P12680EA, Exp. Date 31-Jul-2020 P15461AA, Exp. Date 31-Jul-2020 P15462AA, Exp. Date 31-Aug-2020 P15463AA, Exp. Date 31-Aug-2020 P15870AA, Exp. Date 31-Aug-2020 P15872AA, Exp. Date 31-Aug-2020 P16099AA, Exp. Date 31-Aug-2020 P16100AA, Exp. Date 30-Sep-2020 P16101AC, Exp. Date 30-Sep-2020 P16248AA, Exp. Date 30-Sep-2020 P16770AA, Exp. Date 30-Nov-2020 P16771AA, Exp. Date 30-Nov-2020 R10623AA, Exp. Date 31-Jan-2021 R10624AA, Exp. Date 31-Jan-2021 R10980AA, Exp. Date 31-Jan-2021 R11085AA, Exp. Date 31-Jan-2021 R11086AA, Exp. Date 31-Jan-2021 R11088AA, Exp. Date 28-Feb-2021 R11343AA, Exp. Date 28-Feb-2021 R11416AA, Exp. Date 28-Feb-2021 R11417AA, Exp. Date 28-Feb-2021 R11418AA, Exp. Date 28-Feb-2021 R11419AA, Exp. Date 28-Feb-2021 R12100AA, Exp. Date 28-Feb-2021 R12101AA, Exp. Date 28-Feb-2021 R12102AA, Exp. Date 31-Mar-2021 R12263CA, Exp. Date 31-Mar-2021 R12264AA, Exp. Date 31-Mar-2021 R12598AA, Exp. Date 31-Mar-2021 R12599AA, Exp. Date 31-Mar-2021 R12858AA, Exp. Date 30-Apr-2021 R12859AA, Exp. Date 30-Apr-2021 R12860AA, Exp. Date 31-Jul-2021 R12861AA, Exp. Date 31-Jul-2021 R14321AA, Exp. Date 30-Nov-2021 R14753AA, Exp. Date 31-Jul-2021 R14865AA, Exp. Date 31-Jul-2021 R14866AA, Exp. Date 31-Jul-2021 R15132AA, Exp. Date 31-Aug-2021 R15133AA, Exp. Date 31-Aug-2021 R15330AA, Exp. Date 31-Aug-2021 R15331AA, Exp. Date 31-Aug-2021 R15332AA, Exp. Date 31-Aug-2021 R15333AA, Exp. Date 31-Aug-2021 R15969AA, Exp. Date 30-Sep-2021 R15970AA, Exp. Date 30-Sep-2021 R16231AA, Exp. Date 30-Sep-2021 R16379AA, Exp. Date 31-Oct-2021 R16403AA, Exp. Date 31-Oct-2021 R16405AA, Exp. Date 31-Oct-2021 R16660AA, Exp. Date 31-Oct-2021 R16696AA, Exp. Date 30-Nov-2021 R16770AA, Exp. Date 31-Oct-2021 R17019AA, Exp. Date 31-Oct-2021 R17020AA, Exp. Date 30-Nov-2021 R17148AA, Exp. Date 30-Nov-2021 S11615AA, Exp. Date28-Feb-2022 S11616AA, Exp. Date 28-Feb-2022 S11617AA, Exp. Date 28-Feb-2022 S11618AA, Exp. Date 28-Feb-2022 S11619AA, Exp. Date 28-Feb-2022 S11620AA, Exp. Date 28-Feb-2022 S11621AA, Exp. Date 28-Feb-2022 S11623AA, Exp. Date 28-Feb-2022 S12026AA, Exp. Date 31-Mar-2022 S12413AA, Exp. Date 31-Mar-2022 S12436AA, Exp. Date 31-Mar-2022 S12437AA, Exp. Date 30-Apr-2022 S12438AA, Exp. Date 31-May-2022 S12439AA, Exp. Date 31-May-2022 b) Physician Samples P16101AA, Exp. Date 30-Sep-2020 R15332AC, Exp. Date 31-Aug-2021 S11625AA, Exp. Date 28-Feb-2022

Affected Packages Involved in this Recall

55566-7501-1 Menopur
55566-7501-2 Menopur
55566-7501-3 Menopur