OT: FDA Recalls StoreBrands of 500 mg Caplets Acetaminophen

Discussion in 'Fibromyalgia Main Forum' started by kjfms, Nov 10, 2006.

  1. kjfms

    kjfms Member

    Original page:

    Acetaminophen Recall Announced

    About 11 Million Bottles of Store-Brand 500-Milligram Caplets Recalled

    By Miranda Hitti

    WebMD Medical New

    Reviewed By Louise Chang, MD on Thursday, November 09, 2006

    Nov. 9, 2006 -- The FDA today announced a recall of about 11 million bottles of store-brand acetaminophen 500-milligram caplets.

    Those caplets are over-the-counter drugs for pain relief and fever reduction.

    They're sold by about 130 companies, including Wal-Mart, CVS, and other drug stores, grocery stores, and wholesalers.

    The recall is due to "small metal fragments found in a small number of these caplets," states an FDA news release.

    The fragments range in size from "microdots" to 8-millimeter pieces of wire, according to the FDA.

    The FDA and the caplets' maker, Perrigo Company of Allegan, Mich., are investigating how those metal fragments got into the caplets.

    So far, no illnesses, injuries, or consumer complaints have been reported to the FDA or Perrigo, according to the FDA.

    The FDA "believes the probability of serious adverse health consequences is remote," the FDA's Jason Brodsky told reporters in a teleconference.

    Brodsky is the FDA's assistant commissioner for external relations.

    "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," Brodsky says.

    Advice for Consumers

    For a full list of the companies that sell store-brand 500 milligram acetaminophen made by Perrigo, visit the FDA's web site at:


    The FDA's web site also lists the recalled batches of the drug. That list is posted at:


    The recalled drugs have expiration dates ranging from September 2006 through August 2009.

    The FDA advises consumers who believe they have the recalled acetaminophen to "discontinue use immediately" and call Perrigo's consumer affairs department at:

    <center>(877) 546-0454</center>

    for further instructions.

    People who think they may have been harmed by the affected caplets should talk to their doctors, says Brodsky.

    "We believe, at present, that this is a relatively small fraction of the total available acetaminophen on the market," the FDA's Douglas Throckmorton, MD, told reporters in the teleconference.

    Throckmorton is the deputy director of the FDA's Center for Drug Evaluation and Research.

    Any adverse reactions to the products should be reported to the FDA's MedWatch program, which can be reached by phone at:

    (800) FDA-1088, by fax at (800) FDA-0178,

    or on the MedWatch web site at:


    Adverse reactions should also be reported by phone to Perrigo's consumer affairs department at:

    <center>(877) 546-0454</center>

    says the FDA.

    Investigation Under Way

    According to the FDA, Perrigo told the FDA about the problem on Nov. 1.

    Perrigo discovered, through its own regulatory quality-control procedures, that their tableting equipment was wearing down prematurely, says the FDA.

    The FDA says Perrigo told the FDA that 70 million caplets went through a metal detector, resulting in the discovery of about 200 caplets containing metal fragments ranging from "microdots" to portions of wire 8 millimeters long.

    Perrigo is working with the FDA on correcting the problem.

    In a Perrigo news release, the company says it bought raw materials for the caplets from a third-party supplier. Perrigo didn't name that supplier.

    John Hendrickson, Perrigo's executive vice president and general manager of Perrigo Consumer Health Care, commented on the recall in Perrigo's news release.

    "Our quality control systems noted trace amounts of metal particulate in a very small number of these caplet products," Hendrickson says.

    "Although the frequency of occurrence is very low, the probability of health risk is remote, and there have been no reports of injuries or illness related to this incident, we are taking this measure to maintain the highest possible product quality standards for our retail customers and their store brand consumers."


    SOURCES: News release, FDA. News release, Perrigo Company. Jason Brodsky, assistant commissioner for external relations, FDA. Douglas Throckmorton, MD, deputy director, Center for Drug Evaluation and Research, FDA. Associated Press.

    [This Message was Edited on 11/11/2006]
  2. kjfms

    kjfms Member

    Oh Bonnie don't be embarrassed -- things happen -- certainly nothing for you to be embarrassed about.

    It sounds like this just a small number -- compared to the large quantity that is manufactured -- got through and they're recalling all of them.

    So hopefully they caught it early.

    So glad you like the picture WV is so beautiful in the winter so northern Michigan must be as well :)

    Gosh Bonnie I am sorry you have had to battle FMS for so long and migraines along with IBS and all of the other symptoms -- how horrible for you.

    Thank you for you prayers and I send good thoughts to you as well :)

    I am sorry you have grandchildren who are showing signs of FMS -- I really hope none of them have it.

    Take care,

  3. NancyMystic

    NancyMystic New Member

    Nothing like an 8-millimeter piece of wire in your acetaminophen to ease the headache, eh?


    P.S. Karen - I'm with Bonnie; your beautiful winter pic makes me feel happy just looking at it.

  4. kjfms

    kjfms Member

    Oh yeah Bonnie I sure do remember those days of nothing but over-the-counter medication for migraine -- I can remember many times I take way too many pills in effort to rid myself of the unbearable pain.

    Well I hate to say but migraines do tend to run in families. My grandmother had them and out of 37 or so grandchildren -- several of us have them.

    Nancy thank you so much :) I am pushing the season just a little but the picture was so lovely I could help myself.

    OMG yeah -- the 8mm piece of wire makes my head hurt more than it has been...LOL

    Take care,

    Karen :)
    [This Message was Edited on 11/12/2006]

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