Drug 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.
D-0327-2015
Product summary
- Event
- Event 70085
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5572 Bottles
- Official record key
drug-enforcement:D-0327-2015
Official wording
Reason: Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.
Code information: Lot #: 7770, Expiry: 02/16
Distribution pattern: U.S. including: LA, AR, TX, MS
Derived failure modes
-
Unknown
Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.