November 28, 2000Touro Brand Allergy, Cough and
Cold Medications Recalled
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),
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),
d) TOURO EX Caplets, (Guaifensin 575 mg), Physician sample,
e) TOURO LA Caplets, (Pseudoephrine HCL 120 mg and
Guaifensin 575 mg), Physician sample.
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.
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