Monday, 23 October, 2017

Drug maker paying $33 million over recalled nonprescription meds

Tylenol Extra Strenth is shown in a medicine cabinet Tylenol Extra Strenth is shown in a medicine cabinet
Carol Daniels | 25 May, 2017, 09:38

The West Virginia Attorney General's office, along with 42 other AGs, have reached a $33 million settlement with Johnson & Johnson subsidiary McNeil-PPC Inc. regarding representation of product quality.

The company pleaded guilty to federal criminal charges related to the metal-laden children's Tylenol in 2015, paying $25 million to the Food and Drug Administration.

"This is common sense: over-the-counter drugs, especially those used to treat children, must be manufactured in accordance with federally mandated standards", said Attorney General Schneiderman.

Florida was among 43 states that sued the company and its Johnson & Johnson Consumer Inc. subsidiary, alleging that they misled consumers into believing that they'd manufactured the medications in FDA-compliant facilities.

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The company must also follow its own internal procedures when manufacturing OTC drugs, fixing manufacturing issues before shipping out drugs, and must produce information about where any recalled drugs were distributed in their states within 60 days of a written request. According to the Complaint, McNeil delivered for introduction into state commerce certain batches of OTC drugs that failed to comply with federal standards, and as such, were deemed adulterated.

"Hundreds of millions" pf packages of popular brands like Tylenol, Benadryl, Pepcid, and Rolaids produced at McNeil's Fort Washington, PA from 2009 to 2011 were recalled in response to reports of "product oddities" like unusual odors and particles in some of the products, the Pennsylvania Office of the Attorney General said in a press release heralding the settlement.

In addition to the monetary penalties, the agreement requires McNeil to reform its marketing practices, including the way it advertises its drugs on its website. Class I recalls involve a reasonable probability that use or exposure to the drug may result in serious detrimental health consequences or death. The state's share of that settlement is $531,816 and will go into the general fund.

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