Jaymac Pharmaceuticals L.L.C. recalls J-TAN D PD Drops (bromphenirame maleate 1 mg and pseudoephedrine hcl 7.5 mg/ teaspoon), 1 fl oz (30 mL) Bottle, Over th…
- Recall date
- December 16, 2014
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0327-2015
- FDA classification
- Class II
- Brand / firm
- Jaymac Pharmaceuticals L.L.C.
- Sold / distributed
- U.S. including: LA, AR, TX, MS
Why it was recalled
Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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