Recalls / Class II
Class IID-752-2014
Product
Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Green Tea & Honey Lemon flavors, packaged in a) 6-count packets per carton (NDC 0067-6426-06, UPC 3 0067-6426-06 8) and b) 1-count packet per card (NDC 0067-6426-01, UPC 3 0067-6426-01 3), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.
- Brand name
- Theraflu
- Generic name
- Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl
- Active ingredients
- Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
- Route
- Oral
- NDC
- 0067-6426
- FDA application
- M012
- Affected lot / code info
- Lot #: a) 10116016, Exp 6/30/2013; 10118931, Exp 7/31/2013; 10121950, Exp 8/31/2013; 10122314, 10122316, 10124226, Exp 9/30/2013; 10124377, 10124379, 10125916, 10128112, 10128114, Exp 10/31/2013; b) 25872801, Exp 7/31/2013
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
- Manufacturer
- Haleon US Holdings LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10401 Hwy 6, Lincoln, Nebraska 68517-9626
Distribution
- Quantity
- 1,202,960 cartons and cards
- 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-752-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.