Novartis Recalls NeoCitran DM Cough and Cold Powder Packets
Novartis is recalling NeoCitran DM Cough & Cold powder packets because they may contain foreign substances. The products were distributed in the U.S., Canada, and other countries.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 specific illnesses or injuries, fitting the criteria for a moderate severity recall involving potential contamination.
Plain-English summary
Novartis Consumer Health is recalling NeoCitran DM Cough & Cold powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton. The recall is due to the potential presence of foreign substances in the product.
The affected product is identified by Lot # 10122293 and an expiration date of 8/31/2013. The products were distributed nationwide in the United States, as well as in Mexico, Russia, Korea, Panama, China, and Canada.
Consumers should stop using the recalled product and return it to the place of purchase for a refund or contact Novartis Consumer Health for further instructions.
The recalled product
- Product
- NeoCitran DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478…
- Manufacturer
- Novartis Consumer Health
- Category
- Drug — Cough & Cold
- Hazard
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 (2)
- Lot #: 10122293
- Exp 8/31/2013.
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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