, 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 Recall
BRONKAID Dual Action Formula
24 Coated Caplets
NAA0B3T, NAA0BDB, NAA0B3P, NAA0B3R, NAA0B3N, NAA070E, NAA070F, NAA03PX, NAA03B5, NAA03B6, NAA02LT,
BRONKAID 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
SOURCE Bayer HealthCare