Recalls / Class II
Class IID-756-2014
Product
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.
- Affected lot / code info
- 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.
Why it was recalled
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Recalling firm
- Firm
- Novartis Consumer Health
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10401 Hwy 6, Lincoln, Nebraska 68517-9626
Distribution
- Quantity
- 3,753,348 cartons
- Distribution pattern
- Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Timeline
- Recall initiated
- 2013-06-18
- FDA classified
- 2014-01-17
- Posted by FDA
- 2014-01-29
- Terminated
- 2014-11-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-756-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.