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ALLEGAN, Mich. — Perrigo Co. has initiated a voluntary, national product recall to the retail level of 18 batches of its store-brand acetaminophen infant suspension liquid 160 mg/5 ml.
The company said Friday that the product, sold in two- and four-ounce bottles with syringes, is being recalled because a small number of packages might contain an oral dosing syringe without dose markings.
Perrigo noted that 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 those dosage markings, consumers can continue to use the product.
Batch numbers for the recalled lots include the store brands Walgreen, Rite Aid, Health Mart, Kroger, Meijer, HEB, Publix, Up & Up (Target Corp.), Leader Drug, Babies R Us, Care One, Equaline, Equate, Harmon Face Values, Healthy Accents and Topcare.
Perrigo said it hasn’t received any reports or complaints related to the defect, and the company hasn’t found any products with missing dose markings after re-examination of product on hand. The recall is being conducted with the knowledge of the Food and Drug Administration.
"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," Perrigo chairman and chief executive officer Joseph Papa said in a statement. "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 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.
The company said that distributors and retailers that have the acetaminophen infant suspension liquid that is being recalled should stop distribution and return product.
