D-0327-2015 Class II Terminated
FDA drug recall D-0327-2015 was initiated by Jaymac Pharmaceuticals L.L.C. on December 16, 2014 and is designated Class II. Reason for recall: Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40. The recall status is terminated (terminated June 1, 2015). Affected quantity: 5572 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 7, 2015
- Initiation Date
- December 16, 2014
- Termination Date
- June 1, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5572 Bottles
Product Description
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.
Reason for Recall
Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.
Distribution Pattern
U.S. including: LA, AR, TX, MS
Code Information
Lot #: 7770, Expiry: 02/16