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May 31, 2000

Pharmacia & Upjohn Recalls Caverject(r) Injection

Kalamazoo, MI (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Pharmacia & Upjohn is conducting a recall of certain Caverject(r) Injection, Rx for intravernosal use only, because of the lack of assurance of sterility with alcohol preps manufactured by the Clinipad Company, packaged with Caverject(r) product.

The recalled products are:

a) Caverject(r) Injection (alprostadil 20mcg), NDC #0009-3701-01

b) Caverject(r) Injection (alprostadil 10mcg), NDC #0009-3778-08

c) Caverject(r) Injection (alprostadil 5mcg), NDC #0009-7212-03

d) Companion pack for Caverject(r) Injection (alprostadil), Rx contains 5 companion packs. Each companion pack contains 2 sterile needles, 1-2 ml sterile syringe assembly and 1 alcohol swab.

According to FDA, the products were distributed Nationwide and internationally and affects all lot numbers.

This ongoing Class II recall was initiated by the company, by letter dated Mach 31, 2000.   This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-375/378-0

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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