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SafetyAlerts
February 27, 2003

Schwarz Pharma Has Recalled Codimal DM Syrup

 (SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
Codimal DM Syrup, For Cough/Colds,(Dextromethorphan hydrobromide 10 mg, Phenylephrine hydrochloride 5 mg, and Pyrilamine maleate 8.33 mg) 118mL (4 Fl oz) and 473mL (1 Pint) bottles. Recall # D-125-3.

CODE
a) Lot 1125601 NDC#0131-5131-70 - 473mL (1 Pint) bottles,
b) Lot 1125602 NDC#0131-5131-64 - 118mL (4 Fl oz) bottles.

RECALLING FIRM/MANUFACTURER
Schwarz Pharma Manufacturing, Seymour, IN, by letter on December 3, 2002. Firm initiated recall is ongoing.

REASON
Cross contamination-product contains traces of iron from another oral iron product.

VOLUME OF PRODUCT IN COMMERCE
a) 706 bottles;
b) 23,683 bottles.

DISTRIBUTION
Nationwide and Guyana, Jamaica, Peru, Dominican Republic, Chile, and Uraguay.

 

 
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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.