Recalls / Class II
Class IID-750-2014
Product
Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and phenylephrine hydrochloride 10 mg), Berry Infused with Menthol & Green Tea flavors and Nighttime formula (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, and phenylephrine hydrochloride 10 mg), Honey Lemon Infused with Chamomile & White Tea flavors; packaged in a) 24-count packets per carton containing 6-count Daytime and 18-count Nighttime packets (UPC 3 0043-6403-24 7); b) 12-count packets per carton containing 6-count Daytime and 6-count Nighttime packets (UPC 3 0043-6403-12 4); Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.
- Affected lot / code info
- Lot #: a) 25777303, 25777304, Exp 5/31/2013; 25777501, 25777502, Exp 6/30/2013; 25777801, 25777802, Exp 7/31/2013; 25777803, 25981801, 25981802, Exp 8/31/2013; 25981803, 26088801, 26088802, Exp 9/30/2013; b) 25596201, 25596202, 25596203, 25596204, 25596205, 25596206, Exp 5/31/2013; 25596207, 25767001, 25767101, 25767102, 25767103, Exp 6/30/2013; 25767002, 25767104, 25767105, 25767106, 25767201, Exp 7/31/2013; 25767202, 25767203, 25767204, 25767205, 25767206, 25981602, 25981603, 25981604, 25981605, Exp 8/31/2013; 25981601, 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
- 917,400 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-750-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.