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

FDA recall notice · announced October 21, 2015 · Ferring Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

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

Reason for recall

Subpotent Drug

Notes

Distribution: Nationwide
Lot/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
Quantity: 32,341 vials
Status: Terminated
Products in this recall event:
- 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 Chlorid (D-0015-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.