FDA recall D-0327-2015

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.

Distribution

U.S. including: LA, AR, TX, MS

Key facts

Status

Terminated

Initiation date

2014-12-16

Report date

2015-01-07

Termination date

2015-06-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sunset, LA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0327-2015