Navigation Links
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 (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 RecallProduct NameLot NumberUPC CodeBRONKAID Dual Action Formula

    24 Coated Caplets

    NAA0B3T, NAA0BDB, NAA0B3P, NAA0B3R, NAA0B3N, NAA070E, NAA070F, NAA03PX, NAA03B5, NAA03B6, NAA02LT,

    300240537879BRONKAID Dual Action Formula

    60 Coated Caplets

    NAA0TF3, NAA0TF2, NAA0TF0, NAA0TF1, NAA0TET, NAA0TEW, NAA0TEX, NAA0HHL, NAA0HHK, NAA0HHN, NAA0HHH, NAA0DK5, NAA0DK4, NAA0DK3, NAA0CHE, NAA0CHD, NAA0B3L, NAA0B3K, NAA09XE, NAA09XB, NAA07H2, NAA09XD, NAA07H1, NAA09XA, NAA09XC, NAA07H3, NAA07H4, NAA05BB, NAA05BA, NAA07H0, NAA070D, NAA070C, NAA03PW, NAA05B9, NAA070B, NAA03B8, NAA03B7, NAA02N1, NAA02LW, 244511P, 244501P, 244481P, 244471P, 244491P, 244451P

    300240537855


    '/>"/>
    SOURCE Bayer HealthCare
    Copyright©2012 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. Bayer Employees Named Rising Stars by Healthcare Businesswomens Association
    2. Regeneron and Bayer Announce Co-Promotion Agreement With Santen For EYLEA® (aflibercept) Injection in Japan
    3. Bayer Partnership Delivers Industry-First Dose Management Offering
    4. Zacks Bull and Bear of the Day Highlights: Discover Financial Services, POSCO, AstraZeneca, Bayer and Takeda Pharmaceutical
    5. U.S. FDA Grants Priority Review to the New Drug Application for Bayers Regorafenib to Treat Patients with Metastatic Colorectal Cancer
    6. Bayer Submits New Drug Application for Regorafenib for the Treatment of Gastrointestinal Stromal Tumors (GIST)
    7. Hagens Berman Sobol Shapiro LLP and Douglas & London P.C. Announce Proposed Class Action Settlement in Bayer Combination Aspirin Products Litigation
    8. MediSapiens sapprête à fournir à Bayer HealthCare Pharmaceuticals une nouvelle application informatique en nuage pour analyser et visualiser les données génomiques multidimensionnelles
    9. MediSapiens liefert neue Cloud-Computing-App zur Analyse und Visualisierung multidimensionaler Genomdaten an Bayer HealthCare Pharmaceuticals
    10. MediSapiens to Provide Bayer HealthCare Pharmaceuticals With a New Cloud Computing Application to Analyze and Visualize Multi-Dimensional Genomics Data
    11. Bayers Second Annual Virtual Walk for Hemophilia Raises Funds, Generates Excitement in the Hemophilia Community
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:6/24/2016)... SAN CLEMENTE, Calif. , June 24, 2016 /PRNewswire/ ... pulmonary function testing company, is now able to perform sophisticated lung ... ndd Medical Technologies , Inc. Patients are ... labs.  Thanks to ndd,s EasyOne PRO ® , ARL patients like ... any needed testing done in the comfort of her own home. ...
    (Date:6/24/2016)...  Arkis BioSciences, a leading innovator in the ... cerebrospinal fluid treatments, today announced it has secured ... led by Innova Memphis, followed by Angel Capital ... Arkis, new financing will accelerate the commercialization of ... of its in-licensed Endexo® technology. ...
    (Date:6/23/2016)... startling report released today, National Safety Council research shows ... plan to eliminate prescription opioid overdoses. Prescription Nation ... the worst drug crisis in recorded U.S. history, assigned a "Making ... , New Mexico , Tennessee ... states, three – Michigan , Missouri ...
    Breaking Medicine Technology:
    (Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture ... said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package ... Final Cut Pro X . Simply select a ProHand generator and drag it ...
    (Date:6/25/2016)... ... 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s ... setting the bar too high can result in disappointment, perhaps even self-loathing. However, those ... goal. , Research from PsychTests.com reveals that behind the tendency to ...
    (Date:6/24/2016)... ... 24, 2016 , ... The Pulmonary Hypertension Association (PHA) learned ... receive two significant new grants to support its work to advance research and ... by recognizing patients, medical professionals and scientists for their work in fighting pulmonary ...
    (Date:6/24/2016)... ... ... People across the U.S. are sharpening their pencils and honing their writing ... which patients and their families pay tribute to a genetic counselor by nominating him ... Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In April, Genome ...
    (Date:6/24/2016)... ... ... recruitment firm Slone Partners is pleased to announce the placement of Suzanne ... of North American Capital Sales at HTG Molecular . , In ... commercialization of the HTG EdgeSeq system and associated reagents in North America. , Headquartered ...
    Breaking Medicine News(10 mins):