FDAClass IIJanuary 7, 2015

J-TAN D PD Drops recall: Labeling Error

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…

Why was J-TAN D PD Drops recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 7770, Expiry: 02/16

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…
Recalling firm
Jaymac Pharmaceuticals L.L.C.
Quantity
5572 Bottles
Distribution
U.S. including: LA, AR, TX, MS
Recall date
January 7, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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