# FDA recall D-073-2013

> **Ferring Pharmaceuticals Inc** · Class III · drug recall initiated 2012-08-23.

## 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.

## Distribution

nationwide

## Key facts

- **Recall number:** D-073-2013
- **Recalling firm:** Ferring Pharmaceuticals Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-08-23
- **Report date:** 2012-12-12
- **Termination date:** 2014-05-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-073-2013

## Citation

> AI Analytics. FDA recall D-073-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-073-2013. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*