Class II · Moderate risk
Endometrin
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Menopur 75 IU (Menotropins)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What 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.
Affected NDCs
55566-7501-02
55566-7501-03
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Menopur menotropins NDC 55566-7501 |
Kit | Ferring Pharmaceuticals Inc. | Rx |
- Recalling firm
- Ferring Pharmaceuticals Inc
- NDC code
- 55566-7501-2
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0299-2021 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Ferring Pharmaceuticals Inc
All 2021 recalls
Class II · Moderate risk
ZOMA-Jet 10 Demonstration Kit
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Class II · Moderate risk
ZOMA-Jet 5 Demonstration Kit
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Class I · High risk
STIMATE (desmopressin acetate)
Superpotent Drug
Other failed specification recalls from 2021
All failed specification recalls
Class II · Moderate risk
Buprenorphine HCl
Crystallization; identified as Buprenorphine free base
Class II · Moderate risk
VANComycin 1g added to 250mL of 0.9% Sodium Chloride
Crystallization: Product appears to be turbid.
Class III · Low risk
Topiramate Tablets
Discoloration
Class II · Moderate risk
Pregabalin Capsules
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
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