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FDA Asks Johnson & Johnson To Stop Marketing Hip System
On Monday, Johnson & Johnson issued its ninth product recall in a year, this one covering millions of 1 Day Acuvue TruEye contact lenses sold in Japan and two dozen other countries in Asia and Europe. The recall followed complaints from customers in Japan of an unusual stinging or pain when inserting the lenses. Johnson & Johnson's Vision Care Inc. business blamed the failure of manufacturing equipment that rinses off substances used in producing the lenses, AP reports.
Johnson & Johnson already is under scrutiny by FDA officials, Congress and federal prosecutors over eight previous U.S. recalls of nonprescription medicines since last September. Those included millions of bottles of Tylenol, other pain relievers and cold medicines for children and adults.
The recalls have involved problems ranging from bacterial contamination and a nauseating smell on containers to drugs that may have the wrong amount of active ingredient and liquid medicines that may contain tiny metal shavings.
A DePuy Orthopaedics spokeswoman said Tuesday that the company has received the warning letter.
"We are reviewing the letter to understand the FDA's concerns and will respond to their request for information," she said by email.
Source-Medindia
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