Novarel¿ — Class III drug recall D-073-2013
Terminated recall by Ferring Pharmaceuticals Inc, reported 2012-12-12, distributed nationwide. Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement
| Recall number | D-073-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ferring Pharmaceuticals Inc, Parsippany, NJ, United States |
| Recall initiated | 2012-08-23 |
| Classified | 2012-11-30 |
| Reported by FDA | 2012-12-12 |
| Terminated | 2014-05-30 |
| Distributed | Nationwide (US) |
| Quantity | 146,867 vials |
| Reason classes | labeling |
| NDC | 55566-1501-00, 55566-1501-01 |
| Lot numbers | 04/13, 09/12, 09/13, 11/13, 12/12, 1C264A, 1H047A, 1H047B, 1H052A, 1H052B, 1H052C, 1M417A, 1M417B, 2A012A, 2A012B, 2C278A, 2C278B, 2C278C, 2C278D, 2C278E |
Product
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 by: DRAXIS Specialty Pharmaceuticals Inc., Quebec, Canada. NDC # 55566-1501-0 is assigned to the vial of NOVAREL and is displayed on the vial label. NDC # 55566-1501-1 is assigned to the unit of sale, which is a carton containing 1 vial of NOVAREL and 1 vial of diluent along with the insert. NDC # 55566-1501-1 is displayed on the unit of sale and is the item subject to recall.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-073-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.