J-TAN D PD Drops (Jaymac) - Mislabeled Dye Content (2014)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Jaymac Pharmaceuticals L.L.C.
Lot Codes / Batch Numbers
Lot #: 7770, Expiry: 02/16
Products Sold
Lot #: 7770, Expiry: 02/16
Jaymac Pharmaceuticals L.L.C. is recalling J-TAN D PD Drops (bromphenirame maleate 1 mg and pseudoephedrine hcl 7.5 mg/ teaspoon), 1 fl oz (30 due to Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, LA, MS, TX
Page updated: Jan 15, 2026