Jaymac Pharmaceuticals Recalls J-TAN D PD Drops Due to Dye Labeling Error
Jaymac Pharmaceuticals is recalling J-TAN D PD Drops because the product is labeled 'Dye Free' but contains Red Dye 40.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a minor labeling error regarding the presence of a dye, which fits the criteria for moderate severity.
Plain-English summary
Jaymac Pharmaceuticals, LLC is recalling 5,572 bottles of J-TAN D PD Drops (brompheniramine maleate 1 mg and pseudoephedrine hcl 7.5 mg/teaspoon), 1 fl oz (30 mL) bottles. The product is an over-the-counter medication manufactured by Sonar Products Inc. The recall is due to a labeling error where the product is labeled 'Dye Free' on the front panel but actually contains Red Dye 40.
The affected product is identified by Lot # 7770 and has an expiration date of 02/16. The product was distributed in the United States, including Louisiana, Arkansas, Texas, and Mississippi.
Consumers who have purchased this product should stop using it and return it to the place of purchase or contact the recalling firm for instructions.
The recalled product
- 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.
- Manufacturer
- Jaymac Pharmaceuticals L.L.C.
- Hazard
- Affected units
- 5,572
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 7770
- Expiry: 02/16
Distribution
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