FDA recall D-177-2013

Product

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-12-07

Report date

2013-03-06

Termination date

2014-04-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morristown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-177-2013