Recalls / Class III
Class IIID-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.
- Affected lot / code info
- Lot #s: a) NAA0B3T, NAA0BDB, NAA0B3P, NAA0B3R, NAA0B3N, NAA070E, NAA070F, NAA03PX, NAA03B5, NAA03B6, NAA02LT. b) 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.
Why it was recalled
Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
Recalling firm
- Firm
- Bayer Healthcare, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 36 Columbia Rd, N/A, Morristown, New Jersey 07960-4526
Distribution
- Quantity
- 1,353,420 Blister Packs
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-12-07
- FDA classified
- 2013-02-28
- Posted by FDA
- 2013-03-06
- Terminated
- 2014-04-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-177-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.