Recalls / Class III

Class IIID-073-2013

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.

Affected lot / code info

Lot Number Expiration Date 1C264A 09/12 1H047A 12/12 1H047B 12/12 1H052A 12/12 1H052B 04/13 1H052C 04/13 1M417A 04/13 1M417B 09/13 2A012A 09/13 2A012B 11/13 2C278A 09/13 2C278B 09/13 2C278C 11/13 2C278D 11/13 2C278E 11/13

Why it was recalled

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.

Recalling firm

Firm

Ferring Pharmaceuticals Inc

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

4 Gatehall Dr Fl 3rd, N/A, Parsippany, New Jersey 07054-4518

Distribution

Quantity

146,867 Vials

Distribution pattern

nationwide

Timeline

Recall initiated

2012-08-23

FDA classified

2012-11-30

Posted by FDA

2012-12-12

Terminated

2014-05-30

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-073-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.