Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63538

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 23, 2012
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Ferring Pharmaceuticals Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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.

D-073-2013
Recall number
D-073-2013
Initiated
August 23, 2012
Classification
Class III
Status
Terminated
Quantity
146,867 Vials

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling; incorrect or missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

nationwide

Field note

Send feedback

We'll only use this to respond to your feedback.