Recall record at a glance
| Official record | D-073-2013 |
|---|---|
| Category | Drug Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Ferring Pharmaceuticals Inc. |
| Report date | Dec 12, 2012 |
| Recall initiation date | Aug 23, 2012 |
| Quantity | 146,867 Vials |
| Location | Parsippany, NJ, United States |
Official 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.
Why the product 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.
Distribution information
nationwide
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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