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Acetaminophen Tylenol Brand Substitute Found to Have Metal Pieces in Pills

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Perrigo manufactures drugs that stores private label-- over 120 stores. Their 500 mg acetaminophen, a generic replacement for the brand name Tylenol, pills, have been found to have small metal particles in them.

They attribute the cause to a supplier of ingredients.

About 200 pills out of 70 million were found to contain the metal particles.

Only the 500 mg pills had metal in them.

Tylenol brand acetaminophen is not affected. Since many chain stores are pulling their store brands, this will be a real boon to Tylenol sales.

Unfortunately, in an over-reaction, many chain stores appear to be pulling the more affordable generic drugs from their shelves.

Here is the FDA announcement of the voluntary recall. Note that it contains a link so you can check to see if your medicine is from one of the batches identified as possibly containing metal.
FDA Informs Public of Nationwide Recall of 500mg Strength Store-Brand Acetaminophen Caplets

The U.S. Food and Drug Administration (FDA) is alerting the public to a voluntary recall being conducted by Perrigo Company (Perrigo) of Allegan, Michigan for 383 lots of acetaminophen 500mg caplets manufactured and distributed under various store-brands as a result of small metal fragments found in a small number of these caplets. Approximately 11 million bottles containing varying quantities of acetaminophen 500mg caplets are affected by this recall. For a list of batches affected, please see www.fda.gov/oc/po/firmrecalls/perrigo/perrigobatchlist.html. Consumers can determine if they are in possession of a recalled product by locating the batch number printed on the container label. A list of stores that carry store-brands potentially affected by this recall is located on FDA's website at www.fda.gov/oc/po/firmrecalls/perrigo/perrigocustlist.html.

To date, there have been no illness or injuries received related to this problem and no consumer complaints have been reported to the FDA or to Perrigo. Based on information currently available, the FDA believes the probability of serious adverse health consequences is remote; however if a consumer were to swallow an affected caplet, it could result in minor stomach discomfort and/or possible cuts to the mouth or throat. Consumers should consult their physician if they suspect they've been harmed by use of this product.

Consumers who believe they are in possession of the affected products should discontinue use immediately and call Perrigo's Consumer Affairs Department, 877-546-0454 for further instructions. Any adverse reactions experienced with the use of this product should be reported to Perrigo at the above number and the FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178 or on the MedWatch website at www.fda.gov/medwatch.

FDA is currently investigating the cause of the metal particles found in the acetaminophen 500 mg. caplets. Perrigo originally informed FDA of this problem after discovering through their own regulatory quality control procedures that their tableting equipment was wearing down prematurely. The company is also investigating the cause of the problem. The ongoing investigations have revealed the presence of the metal fragments in caplets of acetaminophen, 500 mg. Perrigo reported to the FDA that 70 million caplets were passed through a metal detector; resulting in the discovery of approximately 200 caplets containing metal fragments ranging in size from "microdots" to portions of wire 8 mm in length.

At this time FDA does not anticipate that this action will cause a shortage of acetaminophen. Currently, only one strength (500 mg caplets) is affected. Consumers may wish to take additional amounts of the lower strengths of acetaminophen tablets or caplets, which are not affected by this recall, to reach the 500 mg dose or access acetaminophen produced by alternate manufacturers. In all instances, FDA advises consumers to follow labeled instructions for maximum daily dosage.

Perrigo is notifying its distributors and retailers of this issue and will inform them of steps it will take to facilitate product replacement.
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Rob Kall has spent his adult life as an awakener and empowerer-- first in the field of biofeedback, inventing products, developing software and a music recording label, MuPsych, within the company he founded in 1978-- Futurehealth, and founding, organizing and running 3 conferences: Winter Brain, on Neurofeedback and consciousness, Optimal Functioning and Positive Psychology (a pioneer in the field of Positive Psychology, first presenting workshops on it in 1985) and Storycon Summit Meeting on the Art Science and Application of Story-- each the first of their kind.  Then, when he found the process of raising people's consciousness and empowering them to take more control of their lives  one person at a time was too slow, he founded Opednews.com-- which has been the top search result on Google for the terms liberal news and progressive opinion for several years. Rob began his Bottom-up Radio show, broadcast on WNJC 1360 AM to Metro Philly, also available on iTunes, covering the transition of our culture, business and world from predominantly Top-down (hierarchical, centralized, authoritarian, patriarchal, big)  to bottom-up (egalitarian, local, interdependent, grassroots, archetypal feminine and small.) Recent long-term projects include a book, Bottom-up-- The Connection Revolution, debillionairizing the planet and the Psychopathy Defense and Optimization Project. 

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Over 200 podcasts are archived for downloading here, or can be accessed from iTunes. Rob is also (more...)
 

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