Home / Recalls / Ferring Pharmaceuticals Inc / D-0015-2016

D-0015-2016 Class III Terminated

Recalled by Ferring Pharmaceuticals Inc — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
October 21, 2015
Initiation Date
September 9, 2015
Termination Date
November 18, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32,341 vials

Product Description

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

Reason for Recall

Subpotent Drug

Distribution Pattern

Nationwide

Code 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

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  • D-1426-2014 Class III — ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufa (September 19, 2013)
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