Drug recall
Novarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE ONLY Rx Only NDC…
FDA recall event 63538 · Class III · Ferring Pharmaceuticals Inc
Key facts
| Event ID | 63538 |
|---|---|
| Recall numbers | D-073-2013 |
| Recalling firm | Ferring Pharmaceuticals Inc |
| Product type | Drugs |
| Products | Novarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE ONLY Rx Only NDC 55566-1501-0 Manufactured for : Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 Manufactured… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with urinary-derived hCG products. |
| Initiation date | Aug 23, 2012 |
| Report date | Dec 12, 2012 |
| Termination date | May 30, 2014 |
| City | Parsippany |
| State | NJ |
| Country | United States |
| FEI number | 1000119907 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: