![]() ![]() Under the plea agreement, the company will pay a criminal fine of $150 million, which includes forfeiting assets of $10 million. SB Pharmco has agreed to plead guilty to a criminal felony for releasing into interstate commerce adulterated Kytril, Bactroban, Paxil CR and Avandamet, in violation of the FDCA. Finally, the criminal information alleges that SB Pharmco’s Cidra facility suffered from longstanding problems of product mix-ups, which caused tablets of one drug type and strength to be commingled with tablets of another drug type and/or strength in the same bottle. The criminal information also alleges that Avandamet tablets manufactured by SB Pharmco did not always have the Food and Drug Administration (FDA)-approved mix of active ingredients, and, as a result, potentially contained too much or too little of the ingredient with the therapeutic effect. The splitting, which the company itself called a "critical defect," caused the potential distribution of tablets that did not have any therapeutic effect and tablets that did not contain any controlled release mechanism. The criminal information further alleges that SB Pharmco’s manufacturing process caused Paxil CR two-layer tablets to split. The criminal information filed today alleges that SB Pharmco’s manufacturing operations failed to ensure that Kytril and Bactroban finished products were free of contamination from microorganisms. Under the FDCA, a drug is deemed adulterated if the methods used in, or the facilities or controls used for, its manufacturing, processing, packing or holding did not conform to or were not operated or administered in conformity with current good manufacturing practice to assure that such drug met the requirements as to safety and had the identity and strength, and met the quality and purity characteristics, which it purported or was represented to possess. The Food, Drug and Cosmetic Act (FDCA) prohibits the introduction or delivery for introduction into interstate commerce of any drug that is adulterated. Paxil CR is the controlled release formulation of the popular anti-depressant drug, Paxil, and Avandamet is a combination Type II diabetes drug. Bactroban is a topical anti-infection ointment commonly used to treat skin infections. Kytril is a sterile anti-nausea medication. The drugs, manufactured at the plant between 2001and 2005, are Kytril, Bactroban, Paxil CR and Avandamet. The resolution includes a criminal fine and forfeiture totaling $150 million and a civil settlement under the False Claims Act and related state claims for $600 million. When i posted a status that mentioned my son loves it.my fren suddenly informed me that she gave her son the original flavour coz its different from the orange flavour in term of the benefits/purposes.BOSTON – SB Pharmco Puerto Rico Inc., a subsidiary of GlaxoSmithKline, PLC (GSK), has agreed to plead guilty to charges relating to the manufacture and distribution of certain adulterated drugs made at GSK’s now-closed Cidra, Puerto Rico, manufacturing facility, the Justice Department announced today. Make Scott’s Emulsion a part of your daily routine and you’ll quickly start to see the benefits in your child. Make Scott’s Emulsion a part of your daily routine Scott’s Emulsion comes in both Original and Orange flavours, which makes it even easier for you to give it to them each day. All they need is just one tablespoon each morning. It’s really easy to give your child the benefits of Scott’s Emulsion. It also contains Vitamin A, which is an essential ingredient in your child maintaining their wellbeing. ![]() There’s more to Scott’s Emulsion that assists your child to stay healthy. But Scott’s Emulsion contains Cod Liver Oil that helps to strengthen their natural defences. Your child’s natural defences are often tested when they’re growing up. ![]()
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