Product: J-TAN D PD Drops (bromphenirame maleate 1 mg and pseudoephedrine hcl 7.5 mg/ teaspoon), 1 fl oz (30 mL) Bottle, Over the Counter. Manufactured for JayMac Pharmaceuticals, LLC, Sunset, LA; Manufactured by Sonar Products Inc., Carlstadt, NJ, NDC: 64661-032-30.
Reason for recall: Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.
Recall initiated: 20141216
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated