D-177-2013 Class III Terminated
FDA drug recall D-177-2013 was initiated by Bayer Healthcare, LLC on December 7, 2012 and is designated Class III. Reason for recall: Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label. The recall status is terminated (terminated April 1, 2014). Affected quantity: 1,353,420 Blister Packs.
Recall Details
- Product Type
- Drugs
- Report Date
- March 6, 2013
- Initiation Date
- December 7, 2012
- Termination Date
- April 1, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,353,420 Blister Packs
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.
Distribution Pattern
Nationwide
Code Information
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.