PlainRecalls
FDA Drug Low Class III Terminated

Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caplets per blister pack, UPC 300240537879, b) 60 coated caplets per blister pack, UPC 300240537855, Bayer HealthCare LLC, Consumer Care, P.O. Box 1910, Morristown, NJ, 07962.

Reported: March 6, 2013 Initiated: December 7, 2012 #D-177-2013

Product Description

Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caplets per blister pack, UPC 300240537879, b) 60 coated caplets per blister pack, UPC 300240537855, Bayer HealthCare LLC, Consumer Care, P.O. Box 1910, Morristown, NJ, 07962.

Reason for Recall

Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.

Details

Recalling Firm
Bayer Healthcare, LLC
Units Affected
1,353,420 Blister Packs
Distribution
Nationwide
Location
Morristown, NJ

Frequently Asked Questions

What product was recalled?
Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caplets per blister pack, UPC 300240537879, b) 60 coated caplets per blister pack, UPC 300240537855, Bayer HealthCare LLC, Consumer Care, P.O. Box 1910, Morristown, NJ, 07962.. Recalled by Bayer Healthcare, LLC. Units affected: 1,353,420 Blister Packs.
Why was this product recalled?
Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 6, 2013. Severity: Low. Recall number: D-177-2013.