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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65422

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 06, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Novartis Consumer Health

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 4

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) Cibalenaa (250 mg Acetaminophen, 250 mg Aspirin, 65 mg Caffeine), boxes of 48/4-ct pouches Foreign packaging do not have NDC numbers.

D-843-2013
Recall number
D-843-2013
Initiated
June 06, 2013
Classification
Class II
Status
Terminated
Recalling firm
Novartis Consumer Health
Quantity
a) 4,178,000 pouches; b) 101,300 boxes and c) & d) 38,235 pouches and boxes (combined)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective container: products are packaged in pouches which may not have been fully sealed

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #s a) 10120190, Exp 6/13 and 10121628, Exp 7/13; Lot #s b) 10115658, Exp 5/13; 10116807, Exp 5/13; 10121630, Exp 7/13 and 10125253, Exp 9/13 Foreign Lot #s c) 10120192, Exp 7/13; d)10120272, Exp 7/13, 10121528 Exp 7/13 and 10121958 Exp 8/13

Distribution pattern

Nationwide, Puerto Rico, Brazil and Panama

drug · product 2 of 4

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 250 mg and 65 mg Caffeine) 2-ct pouches. The foreign packaging do not have NDC numbers

D-844-2013
Recall number
D-844-2013
Initiated
June 06, 2013
Classification
Class II
Status
Terminated
Recalling firm
Novartis Consumer Health
Quantity
10,624,000 pouches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective container: products are packaged in pouches which may not have been fully sealed

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot # a) 10116809, Exp 5/13 Foreign: Lot #s b) 10115644 Exp 5/13; 10118226 Exp 5/13; 10118227 Exp 6/13; 10118228 Exp 6/13; 10121956 Exp 8/13 and 10121957 Exp 8/13

Distribution pattern

Nationwide, Puerto Rico, Brazil and Panama

drug · product 3 of 4

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

D-845-2013
Recall number
D-845-2013
Initiated
June 06, 2013
Classification
Class II
Status
Terminated
Recalling firm
Novartis Consumer Health
Quantity
4,422,000 pouches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective container: products are packaged in pouches which may not have been fully sealed

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #s 10110263, Exp 2/14; 10114706, Exp 4/14; 10118209, Exp 5/14; 10120253, Exp 7/14; 10123520, Exp 8/14; 10095199, Exp 7/13; 10102536, 11/2013, 10103950, Exp 12/13

Distribution pattern

Nationwide, Puerto Rico, Brazil and Panama

drug · product 4 of 4

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 packaging do not have NDC number This product was only distributed to Novartis Brazil by the recalling firm

D-846-2013
Recall number
D-846-2013
Initiated
June 06, 2013
Classification
Class II
Status
Terminated
Recalling firm
Novartis Consumer Health
Quantity
472,000 pouches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective container: products are packaged in pouches which may not have been fully sealed

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot # 10121996, Exp 7/13

Distribution pattern

Nationwide, Puerto Rico, Brazil and Panama