Enforcement Report - Week of December 12, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | D-073-2013 |
| Classification | Class III |
| 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 |
| Product Distributed Qty | 146,867 Vials |
| 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. |
Event Detail
| Event Id | 63538 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Ferring Pharmaceuticals Inc |
| City | Parsippany |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-23 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | nationwide |
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