FDAClass IIJanuary 29, 2014

Theraflu Severe Cold & Cough powder packets containing recall

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.

Why was Theraflu Severe Cold & Cough powder packets containing recalled?

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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.
Recalling firm
Novartis Consumer Health
Quantity
917,400 cartons
Distribution
Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Recall date
January 29, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls