Theraflu Powder, For Solution
FDA Recall NDC 0067-6426
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Theraflu (NDC 0067-6426). A significant event, classified as Class II, was initiated on Jun 18, 2013 by Haleon Us Holdings Llc. The reported reason for this action was: "Presence of Foreign Substance: The products are being recalled because they may contain foreign substances."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Jun 18, 2013
Jan 29, 2014
1,202,960 cartons and cards
Recall Profile & Regulatory Data
Event ID
65490
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Novartis Consumer Health
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Termination Date
Nov 04, 2014
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.
Batch or Lot Expiration 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
Affected Packages Involved in this Recall
0067-6426-01Product
0067-6426-06Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
