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DUBLIN, Ireland — Perrigo Co. plc has voluntarily recalled some batches of its children’s guaifenesin liquid in the United States following a recent recall of certain dosing cups by its supplier.
Perrigo said Monday that the recall, to the retail level, involves two batches of its children’s guaifenesin grape liquid (100 mg/5 ml), an expectorant, and three batches of its children’s guaifenesin DM cherry liquid (100 mg guaifenesin and 5mg dextromethorphan HBr/5 ml), an expectorant and cough suppressant, which are sold as private-label or store-brand products in 4-oz. bottles with dosage cup in the box. The recall is being initiated because some packages contain an oral dosing cup with incorrect dose markings.
The recalls include certain lot numbers of store-brand products from CVS/pharmacy and H-E-B for the children’s guaifenesin grape liquid and for CVS/pharmacy, Rite Aid, Kroger and Dollar General for the children’s guaifenesin DM cherry liquid. Private-label products being recalled include certain lot numbers of Sunmark, Topcare, GoodSense and Care One children’s guaifenesin DM cherry liquid.
The use of these products according to labeled instructions with an affected dosing cup is unlikely to result in serious side effects, and no reports related to an overdose have been received to date, Perrigo noted.
“There have been no reports of adverse events to Perrigo as a result of the incorrect dosage markings,” Perrigo chairman and chief executive officer Joseph C. Papa stated, Perrigo is taking this action to maintain the highest possible product quality standards for our retail customers and consumers. We are taking this action because it is the right thing to do.”
Perrigo said it’s notifying its distributors and customers by verbal and e-mail communication, followed by FedEx-delivered communication, and is arranging for return of all recalled products. Distributors and retailers that have the affected batches of children’s guaifenesin grape liquid and/or children’s guaifenesin DM cherry should stop distribution and return product, the company said, adding that the recall is being conducted with the knowledge of the Food and Drug Administration.
Recalled lots, along with their corresponding branded labels, are listed below:
• CVS children’s guaifenesin grape liquid, 4 oz., lot number 5MK0340, expiration 8/2017.
• H-E-B children’s guaifenesin grape liquid, 4 oz., lot number 5LK0592, expiration 8/2017.
• CVS children’s guaifenesin DM cherry liquid, 4 oz., lot number 5LK0630, expiration 3/2017.
• Rite Aid children’s guaifenesin DM cherry liquid, 4 oz., lot numbers 5LK0528 and 5LK0630, expiration 3/2017.
• Kroger children’s guaifenesin DM cherry liquid, 4 oz., lot numbers 5LK0528 and 5LK0630, expiration 3/2017.
• Dollar General children’s guaifenesin DM cherry liquid, 4 oz., lot number 5LK0630, expiration 3/2017.
• Sunmark children’s guaifenesin DM cherry liquid, 4 oz., lot numbers 5LK0528 and 5LK0630, expiration 3/2017.
• Topcare children’s guaifenesin DM cherry liquid, 4 oz.; lot numbers 5LK0528, 5LK0630 and 5LK0779; expiration 3/2017.
• GoodSense children’s guaifenesin DM cherry liquid, 4 oz., lot number 5LK0528, expiration 3/2017.
• Care One children’s guaifenesin DM cherry liquid, 4 oz., lot number 5LK0630, expiration 3/2017.
