Perrigo Initiates Voluntary Product Recall in the U.S. Of Children’s Guaifenesin Grape Liquid and Guaifenesin DM Cherry Liquid Due to a Potential Defect with the Dosage Cup, With 0 Comments, Category: Recalls,
Perrigo Initiates Voluntary Product Recall in the U.S. Of Children’s Guaifenesin Grape Liquid and Guaifenesin DM Cherry Liquid Due to a Potential Defect with the Dosage Cup
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
For Immediate Release
January 11, 2016
Firm Press Release
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
Label Lot number Expiry
H.E.B 5LK0592 08/2017
CVS 5MK0340 08/2017
GUAIFENESIN DM CHRY LIQ 4 OZ
Label Lot number Expiry
Sunmark 5LK0528, 5LK0630 03/2017
Rite-Aid 5LK0528, 5LK0630 03/2017
Topcare 5LK0528, 5LK0630, 5LK0779 03/2017
Kroger 5LK0528, 5LK0630 03/2017
GoodSense 5LK0528 03/2017
Dollar General 5LK0630 03/2017
Care One 5LK0630 03/2017
CVS 5LK0630 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
Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, including but not limited to, the successful integration of the Omega Pharma Invest NV business. These and other important factors, including those discussed under “Risk Factors” in the Company’s Form 10-K for the year ended June 28, 2015, as well as the Company’s subsequent filings with the Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
* We believe that none of the products being recalled were processed or offered through the national office.
* We strongly encourage you to notify your agencies within one business day from receipt of this notice.
* ALL cased and uncased inventories, both at the member level and agency level, need to be checked. This product may have entered member and agency warehouses through salvage, local donations, TEFAP, local purchases, retail pickups, food drives, or other avenues.
* For additional local details, please contact the Health Department(s) for the area(s) your food bank serves.
For full details on the recall, please visit: http://www.fda.gov/Safety/Recalls/ucm481411.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
If you have questions, please contact Wayne Melichar, Food Safety Manager, at firstname.lastname@example.org or 312.629.7263.