Status
Terminated
Drug Enforcement D-177-2013
Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
Classification
Class III
Report Date
March 6, 2013
Termination Date
April 1, 2014
Product Information
- 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.
- Product quantity
- 1,353,420 Blister Packs
- Reason for recall
- Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Bayer Healthcare, LLC
- Address
-
36 Columbia Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-177-2013
- Event ID
- 63821
- Recall initiation date
- December 7, 2012
- Center classification date
- February 28, 2013
- 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.
- More code info
- —