FDA Drug recall D-0299-2021
Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials of Menotropins for injection, 5 single dose vials of 0.9% So…
- FDA Drug
- Class III
- terminated
- Published 2021-03-17
On 2021-03-17 the FDA classified a Class III recall of Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials of Menotropins for injection, 5 single dose vials of 0.9% So… by Ferring Pharmaceuticals, citing failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0299-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-03-02 |
| Published | 2021-03-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ferring Pharmaceuticals |
| Distribution | US |
Product
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.
Reason
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Identifiers
| ndc | 55566-7501-1 |
|---|---|
| ndc | 55566-7501-2 |
| ndc | 55566-7502-0 |
| ndc | 55566-1600-0 |
| ndc | 55566-7501-3 |
| code_info | Lots# a) P12585AC, Exp. Date 31-Mar-2020 P12677AA, Exp. Date 31-Mar-2020 P12678AA, Exp. Date 31-Jul-2020…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. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0299-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.