Key Takeaway
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) Profe by Ferring Pharmaceuticals Inc was recalled on March 2, 2021. The hazard: Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
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) Profe
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.
Hazard / Reason
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Class III: Product that is not likely to cause adverse health consequences.
Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.
Products Affected
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) Profe
DrugsCompany Information
Ferring Pharmaceuticals Inc
Parsippany, NJ, United States
View all 12 recalls by Ferring Pharmaceuticals Inc →Distribution
Distributed nationwide in the USA.
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Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.