The Recall Desk

FDA (Drugs) recall action 65422

Novartis Consumer Health recalled 4 products on 2013-08-14

The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2013-08-14
Critical
0
Units
15,518,000

Why these products were recalled

Defective container: products are packaged in pouches which may not have been fully sealed

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • ModerateFDA (Drugs)··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.

    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…
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2013-08-14

    Novartis Recalls Excedrin Migraine Pouches Due to Incomplete Seals

    Novartis is recalling 10.6 million Excedrin Migraine pouches because the packaging may not be fully sealed, potentially compromising product integrity.

    Product
    Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 203 702 Foreign packaging: b) Excedrin Migrana (Acetaminophen 250 mg, Aspirin…
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2013-08-14

    Novartis Recalls No Doz Max Strength Caffeine Caplets Due to Packaging Defect

    Novartis Consumer Health is recalling No Doz Max Strength caplets because the pouches may not be fully sealed.

    Product
    No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2070 02
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2013-08-14

    Novartis Recalls Excedrin Extra Strength Due to Unsealed Pouches

    Novartis is recalling Excedrin Extra Strength tablets in pouches that may not be fully sealed. The recall covers products distributed in the US, Puerto Rico, Brazil, and Panama.

    Product
    Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes of 50/2-ct packages, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2030 02 Foreign packaging: c) Parsel Forte and d)…
    Category
    Distribution
    1 state