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November 28, 2000

Touro Brand Allergy, Cough and Cold Medications Recalled

Wareham, MA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Darthmouth Pharmaceuticals, Inc. is recalling certain Touro brand prescription allergy, cough and cold medications because of a lack of data to support labeled expiration date.

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

Touro brand Rx (cough and cold; allergy), in unit dose
packages of physician samples as follows:
a) TOURO ALLERGY Capsule, (Brompheniramine Maleate 5.75 mg and Pseudoephedrine 60 mg), Physician sample,
b) TOURO CC Caplets, (Dextromethorphan hydrobromide 30 mg,
Pseudoephrine 60 mg and Guaifensin 575 mg), Physician sample,
c) TOURO DM Caplets, (Dextromethorphan hydrobromide 30 mg and Guaifensin 575 mg), Physician sample,
d) TOURO EX Caplets, (Guaifensin 575 mg), Physician sample,
e) TOURO LA Caplets, (Pseudoephrine HCL 120 mg and
Guaifensin 575 mg), Physician sample.

Recall #D-031/035-1.

LOT Numbers: a) 419; b) 772; c) 471; d) 394C01; e) 699.

PharmaFab, Grand Prairie, Texas.

Darthmouth Pharmaceuticals, Inc., Wareham, Massachusetts (repacker), by letter beginning on October 18, 2000. Firm-initiated recall ongoing.

Connecticut, Massachusetts, Rhode Island.

The amount of product in commerce is approximately as
Touro Allergy 966 boxes of 30 UDPs;
Touro CC 1004 boxes of 30 UDPs;
Touro DM 888 boxes of 30 UDPs;
Touro EX 546 boxes of 30 UDPs;
Touro LA 670 boxes of 30 UDPs.

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 28, 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!

How many did you hear about?

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