D-752-2014 Class II Terminated
FDA drug recall D-752-2014 was initiated by Novartis Consumer Health on June 18, 2013 and is designated Class II. Reason for recall: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. The recall status is terminated (terminated November 4, 2014). Affected quantity: 1,202,960 cartons and cards.
Recall Details
- Product Type
- Drugs
- Report Date
- January 29, 2014
- Initiation Date
- June 18, 2013
- Termination Date
- November 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,202,960 cartons and cards
Product Description
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.
Reason for Recall
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Distribution Pattern
Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
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