May 31, 2000Pharmacia & Upjohn Recalls
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
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