Ferring Recalls Novarel Injection Due to Missing Anaphylaxis Warning
Ferring Pharmaceuticals is recalling Novarel (Chorionic Gonadotropin) vials because the package insert is missing a warning about anaphylaxis.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a violation of labeling or FDA regulations that is not likely to cause adverse health consequences. The hazard is a missing warning statement rather than a direct contamination or defect.
Plain-English summary
Ferring Pharmaceuticals Inc. is recalling Novarel (Chorionic Gonadotropin for injection, USP), 10,000 USP, for intramuscular use. The recall involves 146,867 vials distributed nationwide. The specific issue is a labeling error where the Warnings portion of the Package Insert is missing the statement: "Anaphylaxis has been reported with urinary-derived hCG products."
The affected product is manufactured for Ferring Pharmaceuticals Inc. and by DRAXIS Specialty Pharmaceuticals Inc. The recall covers specific lot numbers with expiration dates ranging from September 2012 to November 2013. The NDC number for the unit of sale is 55566-1501-1.
Consumers and healthcare providers should check their inventory of Novarel against the listed lot numbers and expiration dates. If the product matches the recalled lots, it should be returned to the supplier or Ferring Pharmaceuticals for replacement or refund. Patients should consult their healthcare provider regarding the missing warning information.
The recalled product
- 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 #…
- Manufacturer
- Ferring Pharmaceuticals Inc
- Affected units
- 146,867
Distribution
Distributed nationwide across the United States.
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