Washington DC, Nov. 9, 2006 //Press Release// 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.
Acetaminophen is often used by Lasik laser eye surgery patients
as a method of temporary pain relief.
Approximately 11 million bottles containing varying quantities
of acetaminophen 500mg caplets are affected by this recall. For
a list of batches affected, please see . 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.
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.
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.
