Germany-based Bayer HealthCare’s Consumer Care division has begun a voluntary recall of BRONKAID Caplets Dual Action Formula in consultation with the US Food and Drug Administration (FDA), over labeling issue.
Bayer has identified that certain information was excluded from the product carton label unintentionally and initiated the recall.
The affected BRONKAID product lot number can be found on the interior blister package in black text beside the expiration date and also on the exterior carton containing the blister packaging, which is embossed on the side panel adjacent to the expiration date.
Bayer HealthCare, which sold the product only in the US at retail outlets nationwide, found that certain information was not included in the BRONKAID Drug Facts labeling beginning in January 2012, as part of a routine internal review.
BRONKAID is indicated for relief of bronchial congestion and mild intermittent asthma symptoms.