April 21, 2000
Genentech, Inc. Recalls Certain Lots of Pulmozyme Inhalation
Berlin, PA (SafetyAlerts) - 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
This product withdrawal does not include
notification and product return at the patient level.
Genentech requests that distribution centers and
pharmacies 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
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.
Notice of this product warning was sent via email
to SafeMail subscribers April 21,
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