PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: March 17, 2021 Initiated: March 2, 2021 #D-0299-2021

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.

Reason for Recall

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

Details

Units Affected
1,155,601 cartons/5 vials per carton 12546 physician samples
Distribution
Distributed nationwide in the USA.
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Ferring Pharmaceuticals Inc. Units affected: 1,155,601 cartons/5 vials per carton 12546 physician samples.
Why was this product recalled? ▼
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 17, 2021. Severity: Low. Recall number: D-0299-2021.

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