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Bayer Consumer Care Voluntarily Recalls 56 Lots of BRONKAID Caplets Dual Action Formula due to Product Labeling Error
Date:12/7/2012

MORRISTOWN, N.J., Dec. 7, 2012 /PRNewswire/ -- In consultation with the U.S. Food and Drug Administration (FDA), Bayer HealthCare's Consumer Care division has begun a voluntary recall of BRONKAID Caplets Dual Action Formula.  Bayer initiated the recall after identifying that certain information was inadvertently excluded from the product carton label.  It is important to note that this represents a labeling omission only.  The quality of the product itself is not affected.

The affected BRONKAID product lot number can be found on both the interior blister package (in black text adjacent to the expiration date) as well as on the exterior carton containing the blister packaging (embossed on the side panel next to the expiration date)

  • Product Name:  BRONKAID Caplets Dual Action Formula
  • Package size/UPC:  24  caplets ( UPC 300240537879)  and 60 caplets ( UPC 300240537855)
  • Lot #s: see below list
  • This product was sold only in the U.S. at retail outlets nationwide.

    As part of a routine internal review, the company found that certain information was not included in the BRONKAID Drug Facts labeling beginning in January 2012.  This information, which is available on the product website www.bronkaid.com, advises to:

    Stop use and ask a doctor if

  • your asthma is getting worse (see Asthma Alert)
  • you have difficulty sleeping
  • you have a rapid heart beat
  • you have tremors, nervousness, or seizure
  • Consumers who purchased packages of BRONKAID Caplets Dual Action Formula from a lot included in this recall (details below) should be mindful of the above warning as well as the full Drug Fact labeling, but may continue to use the product.  Consumers with questions or an interest in a refund should contact Bayer.  Consumers should contact our Consumer Relations Call Center at 1(800) 986-3307 (av
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    SOURCE Bayer HealthCare
    Copyright©2012 PR Newswire.
    All rights reserved

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