Recalls / Class III

Class IIID-0015-2016

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

Affected lot / code info

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

Why it was recalled

Subpotent Drug

Recalling firm

Firm

Ferring Pharmaceuticals Inc

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

100 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1149

Distribution

Quantity

32,341 vials

Distribution pattern

Nationwide

Timeline

Recall initiated

2015-09-09

FDA classified

2015-10-14

Posted by FDA

2015-10-21

Terminated

2020-11-18

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0015-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.