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Senior Citizen Alerts
Acetaminophen Caplets for Pain Relief Being
Voluntarily Recalled
Recall of 500mg
caplets that may contain metal fragments
November
10, 2006 – Senior citizens – the age group that most frequently uses
pain relief from medication – should be aware of a voluntary recall 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, according to the U.S. Food and Drug
Administration.
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Approximately 11 million bottles containing varying
quantities of acetaminophen 500mg caplets are affected by this recall
conducted by Perrigo Company (Perrigo) of Allegan, Michigan for 383
lots.
For a list of batches affected, please
click here. 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 that can be reached by
clicking here.
There have been no illness or injuries reported as
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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