Why it was recalled
Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.
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.
Lot numbers, UPCs & expiration codes
Lot #: 7770, Expiry: 02/16
Where it was sold
U.S. including: LA, AR, TX, MS
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0327-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 16, 2014
- FDA report date
- Jan 7, 2015
- Quantity
- 5572 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jaymac Pharmaceuticals L.L.C.
Original FDA data
Every field from FDA enforcement report D-0327-2015, exactly as published.
Show all FDA fields
- City
- Sunset
- State
- LA
- Status
- Terminated
- Country
- United States
- Event ID
- 70085
- Address
- 2085 I49 South Service Road
- Code information
- Lot #: 7770, Expiry: 02/16
- Postal code
- 70584
- Report date
- Jan 7, 2015
- Product type
- Drugs
- Recall number
- D-0327-2015
- Classification
- Class II
- Recalling firm
- Jaymac Pharmaceuticals L.L.C.
- Product quantity
- 5572 Bottles
- Termination date
- Jun 1, 2015
- Reason for recall
- Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- U.S. including: LA, AR, TX, MS
- Recall initiation date
- Dec 16, 2014
- Initial firm notification
- Center classification date
- Dec 29, 2014