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SafetyAlerts
September 28, 2001

Advance Pharmaceutical Recalls Rugby Brand Diphenhist CAPTABS, Antihistamine

Ronkonkoma, NY.  (SafetyAlerts) - The Food and Drug Administration (FDA) said that Advance Pharmaceutical, Inc. is recalling Diphenhist CAPTABS, Antihistamine, (Diphenhydramine HCl) USP, 25 mg, Rugby Brand, 100 count bottles.

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

RECALL NUMBER, PRODUCT AND CODE:
D-304-1 Diphenhist CAPTABS, Antihistamine, (Diphenhydramine HCl) USP, 25 mg, Rugby Brand, 100 count bottles.

Codes:
NDC # 0536-3597-01, Product # 003-5970.
Lot # Expiration Date
00C035 03/2002
00J019 09/2002
00K002 10/2002
01A036 01/2003
01C023 03/2003
01E014 05/2003
01F034 06/2003

REASON:
Misbranding: Carton labeling incorrectly lists inactive ingredients including but not limited to ? color additives.

MANUFACTURER/RECALLING FIRM:
Advance Pharmaceutical, Inc. Ronkonkoma, NY.

RECALLED BY:
Manufacturer, by fax and letter on 8/31/01.

FIRM INITIATED RECALL:
Ongoing.

DISTRIBUTION:
GA.

QUANTITY:
22,866 bottles (100s).

 
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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.