The Recall Desk
LowFDA (Drugs)·D-0299-2021·Announced 2021-03-17

Ferring Recalls Menopur Due to Out-of-Specification pH in Diluent

Ferring Pharmaceuticals is recalling Menopur (menotropins) and its 0.9% Sodium Chloride diluent because the diluent failed pH specifications. The recall covers products distributed nationwide in the USA.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Ferring Pharmaceuticals Inc. is recalling Menopur (menotropins for injection) and its accompanying 0.9% Sodium Chloride Injection, USP diluent. The recall is due to out-of-specification pH results found in the 0.9% Sodium Chloride, USP diluent. The affected products include Menopur 75 IU packaged with 5 single-dose vials of menotropins and 5 single-dose vials of diluent, as well as professional sample kits containing 3 single-dose vials of menotropins and 3 single-dose vials of diluent.

The recall covers 1,155,601 cartons (5 vials per carton) and 12,546 physician samples. These products were distributed nationwide in the USA. The source text lists numerous specific lot numbers and expiration dates for both the commercial cartons and the physician samples.

Consumers and healthcare providers should stop using the affected lots of Menopur and the associated diluent. Patients should consult their healthcare providers for alternative treatment options. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

Product
MENOPUR (MENOTROPINS)
Brand
MENOPUR
Manufacturer
Ferring Pharmaceuticals Inc
Category
Drug — Prescription Injection
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

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Same hazard · ph failure

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