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% So
Check against the official notice below — it lists the full affected range.
Ferring Pharmaceuticals Inc. is recalling Menopur 75 IU (menotropins for injection) because the 0.9% Sodium Chloride Injection, USP included in the product failed to meet pH specifications. The recall affects approximately 1,155,601 cartons, each containing 5 single dose vials, plus 12,546 physician samples that were distributed nationwide in the USA. Multiple lot numbers are affected with expiration dates ranging from March 2020 through August 2021.
The recall record does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Reason for recall: Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP Distribution: Distributed nationwide in the USA. Quantity: 1,155,601 cartons/5 vials per carton 12546 physician samples Lot/code info: 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
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.