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March 8, 2000

Faulding Pharmaceutical Company Recalls Acyclovir Sodium Injection

Charlotte, NC (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Faulding Pharmaceutical Company is recalling certain Acyclovir Sodium Injections because the product failed visible particulate matter specification (calcium sterate particles) prior to expiration date.

According to the FDA, over 572,000 were distributed nationwide.

The recalled antiviral prescription, used to treat herpes viruses was sold in 500 mg/20mL (25mg/mL),20 mL single dose vial and in 1g/40mL (25mg/mL),40 mL single dose vial.  All lot codes are affected by this recall.

This ongoing Class III recall was initiated by Faulding Pharmaceutical Company by letter dated December 22, 1999.  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-223/224-0

Notice of this product warning was sent via email to SafeMail subscribers March 8, 2000.

Selected Recent Recalls

Health Professional:

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

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