Multi-event May 2013 FDA Recall Drug by Novartis Consumer Health

This Multi-event Class III drug recall was voluntarily initiated by Novartis Consumer Health on May 15, 2013 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-738-2014 TERMINATED D-741-2014 TERMINATED D-744-2014 TERMINATED D-742-2014 TERMINATED D-743-2014 TERMINATED D-739-2014 TERMINATED D-740-2014 TERMINATED

Recall Number: D-738-2014

Reason for Recall
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Initiated
05-15-2013
Reported
01-22-2014
Quantity
104,328/32-caplet packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65181
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Novartis Consumer Health
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-04-2014
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

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

Recall Number: D-741-2014

Reason for Recall
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Initiated
05-15-2013
Reported
01-22-2014
Quantity
167,712/24-caplet packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65181
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Novartis Consumer Health
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-04-2014
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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

Recall Number: D-744-2014

Reason for Recall
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Initiated
05-15-2013
Reported
01-22-2014
Quantity
2,978,000/2-caplet packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65181
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Novartis Consumer Health
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-04-2014
Product Description About Product Description
Full technical description of the product.
Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.

Batch or Lot Expiration Information

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

Recall Number: D-742-2014

Reason for Recall
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Initiated
05-15-2013
Reported
01-22-2014
Quantity
98,024/8-caplet packages and 557,548/24-caplet packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65181
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Novartis Consumer Health
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-04-2014
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# 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

Recall Number: D-743-2014

Reason for Recall
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Initiated
05-15-2013
Reported
01-22-2014
Quantity
3,768/8-caplet packages and 300,580/24-caplet packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65181
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Novartis Consumer Health
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-04-2014
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# 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

Recall Number: D-739-2014

Reason for Recall
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Initiated
05-15-2013
Reported
01-22-2014
Quantity
32,256/24-caplet packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65181
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Novartis Consumer Health
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-04-2014
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

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

Recall Number: D-740-2014

Reason for Recall
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Initiated
05-15-2013
Reported
01-22-2014
Quantity
38,856/24-caplet package

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65181
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Novartis Consumer Health
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-04-2014
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

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