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Dear Pharmacist,
Genentech, Inc. is conducting a Voluntary Class II Drug Recall, withdrawing specified lots of Pulmozyme (dornase alfa, recombinant) Inhalation solution, due to a potential packaging defect which could result in ampule leakage. This action will bring closure to the process that was initiated with the Genentech Important Drug Notification issued March 13, 2000.
This product withdrawal is limited to the distributor and sub-distributor levels only, including chain distribution centers and pharmacies. With the knowledge of the US Food and Drug Administration, Genentech is now taking this action, as there has been adequate time for new product to fill the distribution pipeline.
This product withdrawal does not include notification and product return at the patient level.
We request that you take the following action steps:
1) This is a lot specific withdrawal.
Please examine your stock immediately to determine if you have Pulmozyme
inventory NDC# 50242-0100-40 of the lots listed on Attachment #1 only.
2) If so, discontinue distribution
of those lots, complete the Returned Goods Packing Form provided, enclose
it with your returned goods shipment, and affix the pre-addressed Return
Label to the package.
3) Return using Federal Express.
Check X Bill to Recipient in the payment section and return 2-day Service
to:
Genentech will issue a credit through
your wholesaler at the current wholesale acquisition cost plus 5% for the
returned product.
Important: Please continue
to distribute any Pulmozyme with lots not contained on
Attachment #1
Genentech is fully committed to its customers and will continue to provide Pulmozyme. For further clarification, please feel free to contact Genentech Customer Service at (800) 551-2231 or your local Genentech Sales Representative.
We appreciate your assistance with
this matter and apologize for any inconvenience.