Perrigo recalls APAP infant suspension liquid due to the possibility of missing dose markings on the dosing syringe
ALLEGAN, Mich. — Perrigo on Friday 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 because of the remote potential that a small number of packages might contain an oral dosing syringe without dose markings.
“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," stated Joseph Papa, Perrigo president and CEO. "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.”
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, the private label manufacturer stated.
Using an oral syringe without dose markings can result in inaccurate dosing, especially in infants, Perrigo noted.
MusclePharm targets women with new sports nutrition line
DENVER — MusclePharm on Monday announced the launch of FitMiss, a brand of sports nutrition supplements formulated specifically for women, at Walgreens in January.
Launched in March 2013, FitMiss is a complete line of products scientifically developed with specific formulas to help active women achieve their health and fitness goals. The women’s-based protein provides a full day supply of essential nutrients with quality calories and delivers optimal levels of digestive enzymes, vitamins and minerals. The line’s leading product, FitMiss Delight, was nominated for the 2013 Bodybuilding.com "Women’s Supplement of the Year" award, the company noted.
As a daily interactive resource for active women, FitMiss maintains social media connections on both facebook.com/FitMiss and Twitter @IAMFITMISS. Both social media outlets are led by Chady Dunmore, WBFF Bikini World Champion, Fitness Model, and mom, and provide women with easy to follow recipes, workouts and inspiration from professional personal trainers and fitness gurus.
Council for Responsible Nutrition publishes statutory, regulatory guide
WASHINGTON — A new book from a trade group representing makers of dietary supplements details the laws and regulations that govern the industry.
The Council for Responsible Nutrition announced Thursday the release of Dietary Supplement Regulation in the United States, part of the series Springer Briefs in Food, Health and Nutrition. Springer, a scientific publisher, worked with CRN to compile the book, which the organization said could be used as an educational tool for dietary supplement companies, universities and law schools, as well as a reference guide for journalists and regulatory professionals.
The book reviews the various statutes and regulations that oversee the dietary supplement industry, including regulations on dietary ingredients, manufacturing standards, safety, labeling and claims and other issues. CRN VP scientific and regulatory affairs Duffy MacKay wrote the book, along with regulatory counsel Rend Al-Mondhiry, VP scientific and international affairs Jim Griffiths, associate director of scientific and regulatory affairs Haiuyen Nguyen and former senior director of scientific and regulatory affairs Taylor Wallace.
"Springer is known for providing scientific and professional communities with relevant, high-quality information on specialized topics," CRN president and CEO Steve Mister said. "CRN is known for our staff’s depth of knowledge in the area of dietary supplement regulation. We are honored that Springer chose to collaborate with us in publishing this brief."