Recalls / Class II

Class IID-0586-2016

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, Dosage Cup Included, Distributed by CVS Pharmacy Inc, One CVS Drive, Woonsocket, RI, 02895, NDC 59779-288-26.

Affected lot / code info

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

Why it was recalled

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

Recalling firm

Firm

Perrigo Company PLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

515 Eastern Ave, N/A, Allegan, Michigan 49010-9070

Distribution

Quantity

N/A

Distribution pattern

Nationwide

Timeline

Recall initiated

2016-01-08

FDA classified

2016-01-22

Posted by FDA

2016-02-03

Terminated

2016-05-18

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0586-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.