Reported Oct 21, 2015 · Terminated

Bravelle 75 IU (urofollitropin for injection, purified) For Subcutaneous or Intramuscular Injection Only, 1 Carton…

Ferring Pharmaceuticals Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ferring Pharmaceuticals Inc · 100 Interpace Pkwy · Parsippany, NJ · 07054-1149

Is this the product you have?

  • 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 forFerring Pharmaceuticals, Inc. Parsippany, NJ 07054
  • ByFerring Gmbh, Kiel Germany, NDC 55566-8505-6
Lot codes and dates
    • 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
Amount recalled
32,341 vials

Where it was sold

  • Nationwide

Why it was recalled

Subpotent Drug

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 18, 2020 · Data as of Sep 19, 7:10 PM UTC

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