Drug 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.
D-752-2014
Product summary
- Event
- Event 65490
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,202,960 cartons and cards
- Official record key
drug-enforcement:D-752-2014
Official wording
Reason: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Code information: 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
Distribution pattern: Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance