Reported Jan 7, 2015 · Terminated

J-TAN D PD Drops (bromphenirame maleate 1 mg and pseudoephedrine hcl 7.5 mg/ teaspoon), 1 fl oz (30 mL) Bottle, Over…

Jaymac Pharmaceuticals LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Jaymac Pharmaceuticals L.L.C. · 2085 I49 South Service Road · Sunset, LA · 70584

Is this the product you have?

  • 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
  • NDC64661-032-30
Lot codes and dates
  • Lot #: 7770
  • Expiry02/16
Amount recalled
5572 Bottles

Where it was sold

Why it was recalled

Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 1, 2015 · Data as of Sep 19, 7:20 PM UTC

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