Theraflu Sugar-Free Nighttime Severe Cold & Cough Powder Packets Recalled for Foreign Substances
Novartis Consumer Health is recalling Theraflu Sugar-Free Nighttime Severe Cold & Cough powder packets because they may contain foreign substances.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving potential contamination without confirmed harm.
Plain-English summary
Novartis Consumer Health is recalling specific lots of Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon flavor. The recall involves 292,320 cartons, each containing 6 packets. The affected products are identified by the following lot numbers and expiration dates: Lot 10116040 (Exp 6/30/2013), Lot 10119871 (Exp 7/31/2013), and Lot 10122275 (Exp 9/30/2013). The products are distributed by Novartis Consumer Health, Inc., Parsippany, NJ, and carry NDC 0067-6318-06 and UPC 3 0043-6318-06 0.
The recall was initiated because the products may contain foreign substances. The source text does not specify the nature of the foreign substances or report any illnesses or injuries associated with the use of these products.
The affected products were distributed nationwide as well as in Mexico, Russia, Korea, Panama, China, and Canada. Consumers should check their cartons for the specific lot numbers and expiration dates listed above. If they possess these products, they should stop using them and contact Novartis Consumer Health for further instructions or a refund.
The recalled product
- Product
- Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0
- Manufacturer
- Novartis Consumer Health
- Hazard
- Affected units
- 292,320
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: 10116040
- Exp 6/30/2013
- 10119871
- Exp 7/31/2013
- 10122275
- Exp 9/30/2013.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Novartis Consumer Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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