March 8, 2000Faulding 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
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.
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