Reported Dec 12, 2012 · Terminated
Novarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE ONLY Rx Only NDC 55566-1501-0…
Ferring Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ferring Pharmaceuticals Inc · 4 Gatehall Dr Fl 3rd · Parsippany, NJ · 07054-4518
Is this the product you have?
- Novarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE ONLY Rx
- Only NDC 55566-1501-0 Manufactured forFerring Pharmaceuticals Inc., Parsippany
- NJ 07054 Manufactured byDRAXIS 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
- Lot codes and dates
- Lot Number Expiration Date
1C264A09/121H047A12/121H047B12/121H052A12/121H052B04/131H052C04/131M417A04/131M417B09/132A012A09/132A012B11/132C278A09/132C278B09/132C278C11/132C278D11/132C278E11/13
- Lot Number Expiration Date
- Amount recalled
- 146,867 Vials
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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