Mytussin AC Cough Syrup Recall

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SafetyAlerts
June 4, 2003

Morton Grove Has Recalled Mytussin AC Cough Syrup

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

PRODUCT
Mytussin AC Cough Syrup, MGP, (Guaifenesin, USP 100 mg and Codeine Phosphate, USP 10 mg per (5mL) each teaspoon), Sugar-Free, NET: 4 fl oz (118mL), 1 Pint (473mL) and 1 Gallon (3785mL) bottles. Also sold under the following brand name in each container size - Robafen AC Cough Syrup. Recall # D-261-3.

CODE
Lots 24071, 24195, 24337, 24421, 24423, 24492, 24535, 24541, 24591, 24650,24683, 24741, 24071A, 24071E.

RECALLING FIRM/MANUFACTURER
Morton Grove Pharmaceuticals, Inc., Morton Grove, IL, by letters on May 9, 2003. Firm initiated recall is ongoing.

REASON
Subpotent (codeine phosphate-18 month Stability test).

VOLUME OF PRODUCT IN COMMERCE
226,850 - 4 oz; 275,680 - 16 oz; 3,357 - 128 oz bottles.

DISTRIBUTION
Nationwide.