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McNeil spokeswoman Bonnie Jacobs said other makers of pain relievers are likely to make similar changes to their product labels.
Extra Strength Tylenol is manufactured at a J&J factory in Las Piedras, Puerto Rico, where production has been decreased for months because the FDA, concerned about manufacturing and quality problems, is requiring additional reviews and approvals before medicines can be shipped. J&J said shipments of Extra Strength Tylenol should ramp up in the latter part of this year and throughout next year.
Las Piedras is one of three factories implicated in most of the 25 Johnson & Johnson recalls since September 2009, involving tens of millions of bottles of Tylenol and other nonprescription drugs made by McNeil. Several prescription drugs, hip implants and contact lenses made by other J&J subsidiaries also have been recalled.
The recalls, for quality problems ranging from metal shavings and improper levels of active ingredients in some medicines to packaging with a nauseating odor, resulted in a consent decree between McNeil and the FDA this spring.
As a result, Las Piedras and a second factory, in Lancaster, Pa., are under additional scrutiny. The third factory, in Fort Washington, Pa., made children's medicines such as liquid Tylenol. It has been closed since April 2010 and is being gutted and completely rebuilt.
Jacobs said the label changes are not related to the recalls.
Copyright 2011 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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