Codimal Cough Syrup Recall

COPD International Your Support Network

		You can learn to control this disease instead of letting it control you!

		Return To The Main Library <<<<>>>> Return To The HomePage

IFebruary 27, 2003

Codimal DM Syrup Recalled

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.