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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.

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

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

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

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.


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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