J-TAN D PD Drops (bromphenirame maleate 1 mg and pseudoephedrine hcl 7.5 mg/ teaspoon), 1 fl oz (...
FDA Recall #D-0327-2015 — Class II — December 16, 2014
Product Description
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.
Recalling Firm
Jaymac Pharmaceuticals L.L.C. — Sunset, LA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5572 Bottles
Distribution
U.S. including: LA, AR, TX, MS
Code Information
Lot #: 7770, Expiry: 02/16
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated