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SafetyAlerts
July 18, 2000

Triazolam Tablets Recalled by Par Pharmaceutical, Inc.

Spring Valley, NY (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Par Pharmaceutical, Inc. is conducting a recall of certain Triazolam Tablets because of individual impurity specification failure.

PRODUCT
Triazolam Tablets, USP, 0.125 mg and 0.25 mg, Rx product taken orally as sleeping aid, under the following labels:
Par NDC: 49884-453-62 (10x10), 0.125 mg Tablets
49884-453-05 (500), 0.125 mg Tablets
Par NDC: 49884-454-62 (10x10), 0.25 mg Tablets
49884-454-05 (500), 0.25 mg Tablets
Qualitest NDC: 0603-6186-10 (10x10), 0.125 mg Tablets
Qualitest NDC: 0603-6187-10 (10x10), 0.25 mg Tablets.

Recall #D-422/423-0.  Class III

CODE
0.125 mg Tablets:

Mfr. Lot# Par Lot# Control# Size EXP Label
TE030 013635 014152 10x10 5/2000 Par
014153 10x10 5/2000 Qualitest
014154 500s 5/2000 Par
015617 10x10 5/2000 Par
9B126 017499 017587 500s 2/2001 Par
017589 10x10 2/2001 Par
017590 10x10 2/2001 Par
017591 10x10 2/2001 Par

0.25 mg Tablets:

Mfr. Lot# Par Lot# Control# Size EXP Label
TF064 013730 013871 10x10 6/2000 Par
013872 10x10 6/2000 Qualitest
013874 500s 6/2000 Par
9F200 018698 019113 500s 6/2001 Par

MANUFACTURER
Alphapharm Pty Ltd., Carole Park, Old, Australia (bulk tablets).

RECALLED BY
Par Pharmaceutical, Inc., Spring Valley, New York, by letters on March 14 and 24, 2000. Firm-initiated recall ongoing.  This is the first public notice issued by the FDA.

DISTRIBUTION
Nationwide.

QUANTITY
0.125 mg: 10x10s total shipped: 4689 units
500s total shipped : 2661 units
0.25 mg:
10x10s total shipped: 6961 units
500s total shipped : 1385 units.

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 SafeMail subscribers July 18, 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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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.