September 2015 FDA Recall Drug by Ferring Pharmaceuticals Inc
D-0015-2016 - Subpotent Drug

This Class III drug recall was voluntarily initiated by Ferring Pharmaceuticals Inc on September 9, 2015 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0015-2016

Reason for Recall
Subpotent Drug
Initiated
09-09-2015
Reported
10-21-2015
Quantity
32,341 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72181
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ferring Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-18-2020
Product Description About Product Description
Full technical description of the product.
Bravelle 75 IU (urofollitropin for injection, purified) For Subcutaneous or Intramuscular Injection Only, 1 Carton (contains 5 single dose vials of Bravelle, 5 single dose vials of 0.9% Sodium Chloride Inj., USP, 2 mL, and 5 Q-Cap Vial Adaptors) , Rx Only, Manufactured for: Ferring Pharmaceuticals, Inc. Parsippany, NJ 07054, By: Ferring Gmbh, Kiel Germany, NDC 55566-8505-6

Batch or Lot Expiration Information

Lot# 's: K11813A-1, K11813A-2, Exp 01/16; K11813B-1, K11813C-1, Exp 04/16; K13031A-1, K13031B-1, K13031B-2, Exp 05/16 additional lots added: H14942A-1, H14941A-2. H18815A-1, H15815B-1, H15815SMA-1, H16998A-1, H16998SMA-1, K10008A-1, K10008A-2, K11813A-2, K11813B-1, K11813C-1, K13031A-1, K13031B-1, K13031B-2, K13503SMA-1, K13503A-1, K13503B-1, K13512A-1, K13512A-2, K1392A-1, K13921A-2, K13921B-1, K14616A-1, K14616A-2, K15917A-1, K15917SMA-1, K15917SMA-2, K17006AA, K18201AA, K18202AA, L10403AA, L10403AB, L10840AA, L10992AA