Exact FDA event identifier

Event 65181

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

Event summary

Timeline bucket: May 15, 2013
Product types: Drug
Classifications: Class III
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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

7 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 7

Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula and 16 coated caplets nighttime formula *includes antihistamine Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2082-32.

D-738-2014

Recall number: D-738-2014
Initiated: May 15, 2013
Classification: Class III
Status: Terminated
Recalling firm: Novartis Consumer Health
Quantity: 104,328/32-caplet packages

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Code information

Lot # 10116279 exp 05/13 Lot # 10117810 exp 06/13 Lot # 10119274 exp 07/13 Lot # 10121463 exp 07/13

Distribution pattern

Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.

drug · product 2 of 7

Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula *includes antihistamine, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2081-24.

D-739-2014

Recall number: D-739-2014
Initiated: May 15, 2013
Classification: Class III
Status: Terminated
Recalling firm: Novartis Consumer Health
Quantity: 32,256/24-caplet packages

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Code information

Lot # 10119267 exp 07/13 Lot # 10123857 exp 07/13 Lot # 10123888 exp 09/13

Distribution pattern

Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.

drug · product 3 of 7

Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2084-24.

D-740-2014

Recall number: D-740-2014
Initiated: May 15, 2013
Classification: Class III
Status: Terminated
Recalling firm: Novartis Consumer Health
Quantity: 38,856/24-caplet package

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Code information

Lot# 10117243 Exp 06/13 Lot# 10119333 Exp 07/13

Distribution pattern

Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.

drug · product 4 of 7

Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Novartis, distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2081-24

D-741-2014

Recall number: D-741-2014
Initiated: May 15, 2013
Classification: Class III
Status: Terminated
Recalling firm: Novartis Consumer Health
Quantity: 167,712/24-caplet packages

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Code information

Lot# 10117247 06/13 Lot# 10119336 07/13

Distribution pattern

Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.

drug · product 5 of 7

Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) b) 24 coated caplets (NDC 0067-6438-24), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622.

D-742-2014

Recall number: D-742-2014
Initiated: May 15, 2013
Classification: Class III
Status: Terminated
Recalling firm: Novartis Consumer Health
Quantity: 98,024/8-caplet packages and 557,548/24-caplet packages

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

Code information

a) 08 caplets: Lot# 10121228 exp 08/13. b) 24caplets: Lot# 10114814 exp 05/13 Lot# 10117233 exp 05/13 Lot# 10117811 exp 06/13 Lot# 10119338 exp 07/13 Lot# 10121470 exp 07/13 Lot# 10123892 exp 09/13 Lot# 10124161 exp 10/13

Distribution pattern

Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.

drug · product 6 of 7

Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr 10mg , Phenylephrine HCL 5mg, a) 8 coated caplets (NDC 0067-6437-08) b) 24 coated caplets (NDC 0067-6438-24). Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622.

D-743-2014

Recall number: D-743-2014
Initiated: May 15, 2013
Classification: Class III
Status: Terminated
Recalling firm: Novartis Consumer Health
Quantity: 3,768/8-caplet packages and 300,580/24-caplet packages

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Code information

a) 08 caplets: Lot# 10121222 exp 07/13. b) 24 caplets: Lot# 10117231 exp 06/13 Lot# 10117814 exp 06/13 Lot# 10119341 exp 07/13 Lot# 10123425 exp 08/13 Lot# 10124156 exp 10/13

Distribution pattern

Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.

drug · product 7 of 7

Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.

D-744-2014

Recall number: D-744-2014
Initiated: May 15, 2013
Classification: Class III
Status: Terminated
Recalling firm: Novartis Consumer Health
Quantity: 2,978,000/2-caplet packages

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

Code information

Lot# 10118234 Exp 05/13 Lot# 10120254 Exp 05/13 Lot# 10123513 Exp 08/13 Lot#10125262 Exp 09/13

Distribution pattern

Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.