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-1K11813A-2Exp 01/16K11813B-1K11813C-1Exp 04/16K13031A-1K13031B-1K13031B-2
- Exp 05/16 additional lots added
H14942A-1H14941A-2. H18815A-1H15815B-1H15815SMA-1H16998A-1H16998SMA-1K10008A-1K10008A-2K11813A-2K11813B-1K11813C-1K13031A-1K13031B-1K13031B-2K13503SMA-1K13503A-1K13503B-1K13512A-1K13512A-2K1392A-1K13921A-2K13921B-1K14616A-1K14616A-2K15917A-1K15917SMA-1K15917SMA-2K17006AAK18201AAK18202AAL10403AAL10403ABL10840AAL10992AA
- 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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