Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon Infused with Chamomille & White Tea flavors, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-6256-06, UPC 3 0043-6256-06. Also packaged under foreign label: NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, diphenhydramine hydrochloride 25 mg, Soothing Honey Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., UPC 0 58478 10594 9.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #: 1011525, 10115834, Exp 5/31/2013; 10116012, 10116043, 10116045, 10116047, 10116049, 10117462, 10118936 Exp 6/30/2013; 10118683, 10118685, 10118934, 10118938, Exp 7/31/2013; 10122278, 10122280, 1012282, Exp 8/31/2013; 10124331, 10124333, 10124335, 10125908, Exp 9/30/2013; 10125923, 10126909, 10126911, 10127023, 10127026, Exp 10/31/2013. NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief: 10116036, Exp 6/30/2013 and 10122273, Exp 9/30/2013.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Novartis Consumer Health
Reason for Recall:
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon Infused with Chamomille & White Tea flavors, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-6256-06, UPC 3 0043-6256-06. Also packaged under foreign label: NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, diphenhydramine hydrochloride 25 mg, Soothing Honey Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., UPC 0 58478 10594 9.

Product Codes/Lot Numbers:

Lot #: 1011525, 10115834, Exp 5/31/2013; 10116012, 10116043, 10116045, 10116047, 10116049, 10117462, 10118936 Exp 6/30/2013; 10118683, 10118685, 10118934, 10118938, Exp 7/31/2013; 10122278, 10122280, 1012282, Exp 8/31/2013; 10124331, 10124333, 10124335, 10125908, Exp 9/30/2013; 10125923, 10126909, 10126911, 10127023, 10127026, Exp 10/31/2013. NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief: 10116036, Exp 6/30/2013 and 10122273, Exp 9/30/2013.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-756-2014

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