Class II
Terminated
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, Dosage Cup Included, Distributed by CVS Pharmacy Inc, One CVS Drive, Woonsocket, RI, 02895, NDC 59779-288-26.
- Company
- Perrigo Company Plc
- Recall Initiated
- January 8, 2016
- Posted
- February 3, 2016
- Recall Number
- D-0586-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Allegan, MI, United States
Reason for Recall
Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
Distribution
Nationwide
Lot / Code Info
Lot #s: 5MK0340, 5LK0592, Exp 08/17
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