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SafetyAlerts
November 21, 2000

Danbury Pharmacal Recalls Hydrochloride Capsules

Humacao, 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 (stability).

This is the first public notice of this Class III issued by FDA.

PRODUCT
Nortriptyline Hydrochloride Capsules, USP 25 mg, in 500-count bottles, Rx. NDC #0364-2509-02.

Recall #D-017-1.

CODE
Lot #P9E0175 EXP 5/01.

MANUFACTURER
Danbury Pharmacal of Puerto Rico, Inc., Subsidiary of Schein Pharmaceutical, Inc., Humacao, Puerto Rico.

RECALLED BY
Manufacturer, by priority mail on September 12, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
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.

 
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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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.