Bayer Consumer Care Voluntarily Recalls 56 Lots of BRONKAID Caplets Dual Action Formula due to Product Labeling Error

   Bayer Consumer Care Voluntarily Recalls 56 Lots of BRONKAID Caplets Dual
                 Action Formula due to Product Labeling Error

PR Newswire

MORRISTOWN, N.J., Dec. 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)

  oProduct Name: BRONKAID Caplets Dual Action Formula
  oPackage size/UPC: 24 caplets ( UPC 300240537879) and 60 caplets ( UPC
    300240537855)
  oLot #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

  oyour asthma is getting worse (see Asthma Alert)
  oyou have difficulty sleeping
  oyou have a rapid heart beat
  oyou 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 (available Monday - Friday 8:30AM - 5:30PM eastern standard time.)
Any consumer with a medical concern or questions should contact their
healthcare provider.

BRONKAID is indicated for relief of bronchial congestion and mild intermittent
asthma symptoms, the latter of which should be first diagnosed by a
physician. For full product information and directions for use, see
www.bronkaid.com

About Bayer HealthCare
Bayer HealthCare, a subgroup of Bayer AG with annual sales of €17.2 billion
(2011), is one of the world's leading, innovative companies in the healthcare
and medical products industry and is based in Leverkusen, Germany. Bayer
HealthCare combines the global activities of the Animal Health, Consumer Care,
Medical Care and Pharmaceuticals divisions.

Bayer HealthCare's Consumer Care Division is headquartered in Morristown, New
Jersey, USA. It is among the largest marketers of over-the-counter medications
and nutritional supplements in the world. Some of the most trusted and
recognizable brands in the world today come from the Bayer portfolio of
products. These include Bayer^® Aspirin, ALEVE^®, Flanax^®/Apronax^®,
Alka-Seltzer Plus^®, Bactine^®, RID^®, Phillips'^® Milk of Magnesia, Midol^®,
Alka-Seltzer^®, Talcid^®, Rennie^®, Canesten^®, Bepanthen^®, Bepanthol^®,
One-A-Day^® vitamins, FlintstonesTM vitamins, Supradyn^®, Redoxon^®,
Berocca^®, Cal-D-Vita/Elevit^®, Vital 50 Plus^®, CardioAspirin^®.

BRONKAID Lot Numbers Affected by Voluntary Recall

Product Name         Lot Number                                   UPC Code
BRONKAID Dual Action NAA0B3T, NAA0BDB, NAA0B3P, NAA0B3R, NAA0B3N,
Formula              NAA070E, NAA070F, NAA03PX, NAA03B5, NAA03B6, 300240537879
                     NAA02LT,
24 Coated Caplets
                     NAA0TF3, NAA0TF2, NAA0TF0, NAA0TF1, NAA0TET,
                     NAA0TEW, NAA0TEX, NAA0HHL, NAA0HHK, NAA0HHN,
BRONKAID Dual Action NAA0HHH, NAA0DK5, NAA0DK4, NAA0DK3, NAA0CHE,
Formula              NAA0CHD, NAA0B3L, NAA0B3K, NAA09XE, NAA09XB,
                     NAA07H2, NAA09XD, NAA07H1, NAA09XA, NAA09XC, 300240537855
60 Coated Caplets    NAA07H3, NAA07H4, NAA05BB, NAA05BA, NAA07H0,
                     NAA070D, NAA070C, NAA03PW, NAA05B9, NAA070B,
                     NAA03B8, NAA03B7, NAA02N1, NAA02LW, 244511P,
                     244501P, 244481P, 244471P, 244491P, 244451P

SOURCE Bayer HealthCare

Contact: Tricia McKernan, Global Communications, Bayer HealthCare, Consumer
Care Division, +1-866-683-1126, tricia.mckernan@bayer.com
 
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