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August 23, 2001

Zenith Goldline Pharmaceuticals Recalls Perphenazine Tablets

Northvale, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Zenith Goldline Pharmaceuticals is recalling Perphenazine Tablets because of tablet discoloration.

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

RECALL NUMBER, PRODUCT AND CODE:

Perphenazine Tablets,USP, 2mg, 4mg, 8mg, and 16mg Strengths, packaged in 100 and 500 bottles:
D-272-1, Perphenazine Tablets,USP, 2mg
D-273-1, Perphenazine Tablets,USP, 4 mg
D-274-1, Perphenazine Tablets,USP, 8 mg
D-275-1, Perphenazine Tablets,USP, 16 mg

CODE:
Perphenazine Tablets, 2 mg, 4 mg, 8mg, and 16mg strengths:

NDC # 0172-3667-60, NDC # 0172-3668-60, NDC # 0172-3669-60, NDC # 0172-3669-70, NDC #0172-3670-60 and 0172-3670-70

Lot Numbers:
2mg: 3667-103; 3667-105; 3667-106; 3667-107; 3667-108, 3667-109
4mg: 3668-153; 3668-154; 3668-155; 3668-156; 3668-157; 3668-158; 3668-159; 3668-160; 3668-161
8mg: 3669-232; 3669-233; 3669-234; 3669-235; 3669-236; 3669-237; 3669-238; 3669-239; 3669-240; 3669-241; 3669-242; 3669-243; 3669-244; 3669-245; 3669-246; 3669-247
16mg: 3670-081; 3670-082; 3670-083; 3670-084

MANUFACTURER/RECALLING FIRM:
Zenith Goldline Pharmaceuticals, Northvale, NJ

RECALLED BY:
An Urgent Product Recall Letter

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide

QUANTITY:
2mg=12,000,000 tablets;
4mg=18,000,000 tablets,
8mg=16,000,000 tablets,
16mg=4,000,000 tablets

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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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.