The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-846-2013·Announced 2013-08-14

Novartis Recalls Parsel Plus Pouches Due to Potential Sealing Defects

Novartis is recalling 472,000 pouches of Parsel Plus in Brazil and Panama because the packaging may not be fully sealed.

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 hazard is a packaging defect (unsealed pouches) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Novartis Consumer Health is recalling 472,000 pouches of Parsel Plus (Acetaminophen 500 mg and Caffeine 65 mg) in 2-count pouches. The recall affects Lot # 10121996 with an expiration date of 7/13. The product was distributed to Novartis Brazil by the recalling firm.

The recall is due to a defective container issue where the pouches may not have been fully sealed. This product was distributed in Brazil and Panama. The foreign packaging does not have an NDC number.

Consumers should stop using the product and contact Novartis Consumer Health for instructions on disposal or return.

The recalled product

Product
Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis Consumer Health S.A., Brazil, for Novartis de Venezuela. The foreign…
Manufacturer
Novartis Consumer Health
Category
Drug — Pain Relievers
Hazard
Affected units
472,000

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 # 10121996
  • Exp 7/13

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 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.

See all 4 products in this recall →

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