Perrigo Initiates Nationwide Voluntary Product Recall Of Acetaminophen Infant Suspension Liquid, 160 mg/5 mL, Due To A Potential Defect With The Co-Packaged Oral Syringe.
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The Perrigo Company (NYSE: PRGO; TASE) announced today that it has initiated a voluntary, nationwide product recall to the retail level of 18 batches of its acetaminophen infant suspension liquid, 160 mg/5 mL, sold in 2 oz. and 4 oz. bottles with syringes in a box under the store brand products listed below. The recall is being initiated because of the remote potential that a small number of packages might contain an oral dosing syringe without dose markings. The correct syringe should have a white or yellow plunger with specific dose markings for 1.25 mL, 2.5 mL, 3.75 mL, and 5 mL. If the product’s syringe has these dose markings, consumers can continue to use the product while following labeled use instructions.
Using an oral syringe without dose markings can result in inaccurate dosing, especially in infants who could mistakenly get too high a dose.
Commenting on this market action, Perrigo’s Chairman, President and CEO Joseph C. Papa stated, “There are no issues or concerns with respect to the safety or efficacy of the product, only the potential that the oral dosing device in a relatively small number of packages could be unmarked. Out of an abundance of caution, we are taking this measure to maintain the highest possible product quality standards for our retail customers and consumers. While we cannot be certain that any of these unmarked dosing devices were released into our customers’ supply chains, taking this action is the right thing to do.” Perrigo has not received any reports or complaints related to this defect nor have they found any product with missing dose markings on re-examination of product on hand.
This OTC product is indicated for the relief of fever and minor aches and pains and can be used in infants, children and adults. 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 today, followed by formal FedEx-delivered communication. It also is arranging for return of all recalled products. Distributors/retailers that have the acetaminophen infant suspension liquid that is being recalled should stop distribution and return product.
If the oral dosing device contained in the package has dose markings, no action is required, and the consumer can continue to use the product consistent with the label instructions. If the package contains an oral dosing device that does not have dose markings, the consumer should not use the product and should call Perrigo’s Consumer Affairs Department, toll free, 1-800-719-9260. 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.
Perrigo Company has a market cap of $13.4 billion is based in Allegan, Michigan. The Company develops, manufactures and distributes over-the-counter (“OTC”) and generic prescription (“Rx”) pharmaceuticals, nutritional products and active pharmaceutical ingredients (“API”) and is the world’s largest manufacturer of OTC pharmaceutical products for the store brand market.
Adverse events that may be related to the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
Regular Mail: use postage-paid FDA form 3500 available at:
Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
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:
BABIES R US
3HK0672, 3JK0433, 3JK0594, 3JK0595, 3JK0653, 3JK0673, 3KK0815,
HARMON FACE VALUES
3GK0645, 3GK0704, 3HK0671, 3JK0433, 3JK0595, 3JK0653, 3JK0433,
3JK0595, 3GK0645, 3GK0704, 3JK0595
UP & UP
3GK0704, 3HK0564, 3HK0671, 3JK0433, 3JK0595, 3JK0610, 3KK0360
Mr. Papa concluded by stating, “While patient safety remains our top priority, we do not expect this issue to have a material financial impact on the company, and we are reaffirming our Fiscal 2014 full-year’s earnings guidance provided October 31, 2013.”