Pulmozyme (dornase alfa, recombinant) Dear Pharmacist 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.
Specified Lots Only :
Pulmozyme (dornase alfa) Inhalation Solution
April 17, 2000
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:
Attn: Materials Control Receiving
437 Kaufmann Court
South San Francisco, CA 94080
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
4) When dispensing Pulmozyme, please continue to instruct patients to follow the steps outlined in the initial correspondence, to insure that the ampules are not compromised.
- Visually inspect all of the ampules to determine whether the appropriate levels of liquid are in the ampules. If any ampule appears to be only partially full they should be returned.
- Even if the ampules appear full, please have them test for leaks by gently applying pressure to each ampule. If there appears to be a leak, set aside and return.
Please note that Genentech will be revising our package insert to instruct patients to always inspect ampules prior to administering Pulmozyme.
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.
1 DNA Way
South San Francisco, CA 94080-4990