Perrigo Recalls 11 Million Bottles of Acetaminophen

News
Article

ePT--the Electronic Newsletter of Pharmaceutical Technology

Over-the-counter drug maker Perrigo Company issued a voluntary recall of certain lots of store-brand acetaminophen 500-mg caplets that could contain trace amounts of metal particulate. Approximately 11 million bottles of acetaminophen are affected by the recall.

Allegan, MI (Nov. 9)-Over-the-counter drug maker Perrigo Company (www.perrigo.com) issued a voluntary recall of certain lots of store-brand acetaminophen 500-mg caplets that could contain trace amounts of metal particulate. Approximately 11 million bottles of acetaminophen are affected by the recall.

After discovering that its tableting equipment was wearing down prematurely, Perrigo reported the contamination to the US Food and Drug Administration on Nov. 2, 2006. The company told Pharmaceutical Technology that the unusual wear was detected and investigated through the company’s internal quality-control procedures. An investigation found metal particulate contamination and traced it back to a third-party supplier of a raw material.

In the investigation, Perrigo reported, 70 million caplets were passed through a metal detector and 200 caplets were found to contain metal fragments. The size of the particles ranged from "microdots" to 8 mm in length. To date, no serious health effects have been reported, but tablets containing metal particles could cause stomach discomfort and possible cuts to the mouth or throat.

 

 

Recent Videos
Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Miguel Forte from ISCT and Kiji Therapeutics chats about expectations for 2025 and the future technology agenda for industry.
Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.
Related Content