SOUTH SAN FRANCISCO, Calif. — May 22nd, 2015 — Counterfeiting of Nutropin AQ®
Dear Pharmacist, Health Care Professional and Patient:
Genentech, Inc. recently became aware of the existence in the U.S. of a counterfeit drug product labeled as Nutropin AQ® 10 mg vials in 6-pack boxes. In cooperation with the U.S. Food and Drug administration (FDA), Genentech is informing patients, physicians, pharmacies and wholesalers about this serious health risk. The safety of our patients is of utmost importance and we are cooperating fully with the FDA to investigate this matter and prevent the further distribution of counterfeit product. To our knowledge, the counterfeit product has only been found in distribution in the U.S.
In at least one case the FDA has determined that a vial contained human insulin. In the event that patients have used the counterfeit product they should contact their physician immediately.
The counterfeit product, which is definitely not Nutropin AQ®, was neither manufactured nor distributed by Genentech and may pose a serious health risk to patients. The following Lot Numbers/Expiration Dates have been identified as potential counterfeit drug. Please follow information below to confirm:
Lot No. L9101A4, Expiration May 2002
Lot No. L9504A2, Expiration April 2002
Lot No. L9504A3, Expiration December 2001
The following information may help in determining if the product you have is counterfeit or actual Nutropin AQ® manufactured and distributed by Genentech. Pharmacists, all other health care providers and patients should examine the product before use.
Below are a list of features to compare counterfeit product with authentic Nutropin AQ® with pictures illustrating these differences.
Physicians, please convey this information to your staff and any others who prescribe this product so you can all help alert patients. If you, your staff, or your patients suspect that you are in possession of any counterfeit product, please contact your dispensing pharmacy or contact the FDA Drug Information Branch, Center For Drugs, at (301) 827-4570.
Distributors, if you receive any product that you suspect is counterfeit, quarantine it, store it under labeled conditions, and promptly contact the FDA Division of Drug Information at (301) 827-4570.
Six Pack Carton:Figure 1
Six Pack Carton:Figure 1
Patient Insert:
Vial Label:Figures 2 & 3
Patient Insert:
Vial Label:Figures 2 & 3
Vial:Figure 3
Vial:Figure 3
Product Solution:
Flip Cap:
Aluminum Seal:Figure 4
Product Solution:
Flip Cap:
Aluminum Seal:Figure 4
Stopper:Figure 5
Stopper:Figure 5
Other Contact Information FDA Media Contact: Laura Bradbard (301) 827-6252
Genentech Customer Service Department: (800) 551-2231
Genentech Media Contacts: Marie Kennedy (650) 225-8751 or Sabrina Johnson (650) 225-2742
Nutropin AQ® is used for the treatment of growth failure due to inadequate endogenous growth hormone secretion in children and is self-administered daily through subcutaneous injection.
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.