November 21, 2000Danbury Pharmacal Recalls
Puerto Rico (SafetyAlerts) - The
Food and Drug Administration (FDA) said today that Danbury Pharmacal of Puerto Rico, Inc.
is recalling certain Nortriptyline Hydrochloride Capsules because of dissolution failure
This is the first public notice of
this Class III
issued by FDA.
Nortriptyline Hydrochloride Capsules, USP 25 mg, in 500-count bottles, Rx.
Lot #P9E0175 EXP 5/01.
Danbury Pharmacal of Puerto Rico, Inc., Subsidiary of Schein Pharmaceutical, Inc.,
Humacao, Puerto Rico.
Manufacturer, by priority mail on September 12, 2000. Firm-initiated recall ongoing.
6,756 bottles were distributed.
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.
Notice of this product warning was sent via email
to SafetyAlerts subscribers November
21, 2000. For more information regarding the SafetyAlerts free email alert service
please click here.
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