FDA-Drug2021-03-17Class III
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.
Ferring Pharmaceuticals Inc
Hazard
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Sold states
Distributed nationwide in the USA.
Affected count
1,155,601 cartons/5 vials per carton 12546 physician samples
Manufactured in
100 Interpace Pkwy, Parsippany, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0299-2021Don't want to check this manually?
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