Perrigo Company PLC: Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

Agency Publication Date: January 22, 2016

Affected Products

Product: Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) H.E.B. Mucus Relief, Children's Guaifenesin, Expectorant, Age 4+, Grape Flavor, Gluten Free, Alcohol Free, 4 FL OZ (118 mL) Bottle, Made for: H.E.B. San Antonio, TX 78204, NDC 37808-288-26; b) CVS, Children's Mucus Relief Chest Congestion, Guaifenesin, Expectorant, Alcohol free, Gluten free, 4 FL OZ (118 mL) Bottle, For Ages 4 to 12 Years, Grape Flavor Liquid

Lot #s: 5MK0340, 5LK0592, Exp 08/17

Product: Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 mL), packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) Sunmark, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: McKesson, San Francisco, CA 94104, NDC 49348-828-34; b) Rite-Aid, Children's Mucus Relief Cough, Guaifenesin

Lot #s: 5LK0528, 5LK0630, 5LK0779, Exp 03/17

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73044

Status: Resolved

Manufacturer: Perrigo Company PLC

Manufactured In: United States

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot #s: 5MK0340, 5LK0592, Exp 08/17

Lot #s: 5LK0528, 5LK0630, 5LK0779, Exp 03/17