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U.S. Department of Health and Human Services

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Pulmozyme (dornase alfa, recombinant) Dear Distributor Letter Apr 2000

FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.


This is the retyped text of a letter from Genentech, Inc. Contact the company for a copy of any referenced enclosures.


Urgent - Drug Recall
Specified Lots Only :
PulmozymeÒ (dornase alfa) Inhalation Solution
NDC# 50242-0100-40

April 17, 2000

Dear Distributor,

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.

As a result, 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, Inc.
Attn: Materials Control Receiving
437 Kaufmann Court
South San Francisco, CA 94080

A credit calculated using the NWDA standard rate will be issued to your account for the returned product.

Important: Please continue to distribute any Pulmozyme with lots not contained on Attachment #1

4) Please complete and return the Business Reply Letter, immediately, even if you no longer have Pulmozyme in your inventory.
5) If you have distributed to your accounts Pulmozyme listed on Attachment #1, please contact them immediately. Advise them of this action and instruct them to return any affected lots to Genentech. Please copy the enclosed "Dear Pharmacist" letter, Attachment #1 and Return Goods Packing Form and send them to your pharmacy accounts. You will be compensated for notifying your customers at the NWDA standard rate.

Please note: Any shipments received from Genentech after March 13, 2000 ARE NOT AFFECTED by this drug recall.

Genentech is fully committed to its customers and will continue to provide Pulmozyme. If you need any additional information, please feel free to contact Genentech Customer Service at (800) 551-2231or your local Genentech Sales Representative.

We appreciate your assistance with this matter and apologize for any inconvenience.

 



Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080-4990
(800) 551-2231