Silver Spring, Maryland–(ENEWSPF)–January 13, 2016. Perrigo Company plc (NYSE: PRGO; TASE) of Dublin, Ireland, announced today that, following the recent recall of certain dosing cups by its supplier, it has initiated a voluntary product recall in the US to the retail level of 2 batches of its children’s guaifenesin grape liquid (100mg/5 mL) and 3 batches of its children’s guaifenesin DM cherry liquid (100mg guaifenesin and 5mg dextromethorphan HBr/ 5 ml) sold in 4 oz. bottles with dosage cup in a box under the store brand products listed below. This recall is being initiated because some packages contain an oral dosing cup with incorrect dose markings.
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 overdose have been received to date. Consumers should be aware that an overdose of Guaifenesin DM may cause hyper excitability, rapid eye movements, changes in muscle reflexes, ataxia, dystonia, hallucinations, stupor, and coma. Other effects have included nausea, vomiting, tachycardia, irregular heartbeat, seizures, respiratory depression, and death. Gastric decontamination is recommended after acute ingestion of greater than 10 mg/kg, if administered soon after ingestion. At risk populations such as those who are poor metabolizers of dextromethorphan may experience an overdose by a factor of 3, if incorrect measuring levels are used. Additionally, small children who are poor metabolizers of dextromethorphan and use the product regularly over a period of several days at the mistaken dose, may develop cumulative toxicity. Moreover, adverse reactions to guaifenesin when given in high or excessive dosage may include nausea/vomiting, diarrhea, and/or abdominal pain. Therefore, an extreme overdose in an at risk population may need medical intervention, but in most cases adverse health consequences are temporary and reversible.
Commenting on this market action, Perrigo’s Chairman and CEO Joseph C. Papa stated, “There have been no reports of adverse events to Perrigo as a result of the incorrect dosage markings. 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.”
These OTC products are indicated for helping loosen phlegm (mucus) and thin bronchial secretions and making coughs more productive, as well as in the case of the DM product to temporarily relieve: coughs due to minor throat irritations, the intensity of coughing, and the impulse to cough. These recalled products are sold by distributors nationwide and distributed through retail stores.
Perrigo is notifying its distributors and customers by verbal and e-mail communication, followed by formal FedEx-delivered communication. It also is arranging for return of all recalled products. Distributors/retailers that have the affected batches of children’s guaifenesin grape liquid and/or children’s guaifenesin DM cherry that is being recalled should stop distribution and return product.
Consumers that have product with the corresponding labels and batch numbers listed below should discard the dosing device and product and may call Perrigo, toll free, Monday through Friday from 8:00 AM to 10:00 PM EST, at 1-888-345-0479, or visit mucusreliefrecall.com. Consumers should contact their physician or healthcare provider if they have any questions, or if they or their children experience any problem that could possibly be related to this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm, then complete and return to the address on the pre-addressed form.
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Recalled lots, along with their corresponding branded labels, are listed below:
GUAIFENESIN GRAPE LIQ 4 OZ
GUAIFENESIN DM CHRY LIQ 4 OZ
|Topcare||5LK0528, 5LK0630, 5LK0779||03/2017|
Perrigo Company plc is a top five global over-the-counter (“OTC”) consumer goods and leading specialty pharmaceutical company, offering patients and customers high-quality products at affordable prices. From the Company’s beginning in 1887 as a packager of home remedies, it has grown to become the world’s largest manufacturer of OTC healthcare products and supplier of infant formulas for the store brand market. The Company is also a leading provider of generic extended topical prescription products, and it receives royalties from sales of the multiple sclerosis drug Tysabri®. The Company provides “Quality Affordable Healthcare Products®” across a wide variety of product categories and geographies, primarily in North America, Europe and Australia, as well as in other markets, including Israel and China. Visit Perrigo online at (http://www.perrigo.com).
Forward Looking Statements
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