PlainRecordsFDA · Drug recall
Maximum Strength Comtrex Day/Night Cold & Cough… and 6 more products
- Date
- Jan. 22, 2014
- Risk class
- Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)
- Status
- Terminated
- Filed by
- Novartis Consumer Health
- Distribution pattern
- Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
7 products in this recall
Maximum Strength Comtrex Day/Night Cold & Cough…
- 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.
- Reason
- Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
- Quantity
- 104,328/32-caplet packages
- Codes and lots
- Lot # 10116279 exp 05/13 Lot # 10117810 exp 06/13 Lot # 10119274 exp 07/13 Lot # 10121463 exp 07/13
- Recall started
- May 15, 2013
- Recall number
- D-738-2014
Maximum Strength Comtrex Nighttime Cold & Cough…
- 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.
- Reason
- Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
- Quantity
- 32,256/24-caplet packages
- Codes and lots
- Lot # 10119267 exp 07/13 Lot # 10123857 exp 07/13 Lot # 10123888 exp 09/13
- Recall started
- May 15, 2013
- Recall number
- D-739-2014
Maximum Strength Comtrex…
- 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.
- Reason
- Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
- Quantity
- 38,856/24-caplet package
- Codes and lots
- Lot# 10117243 Exp 06/13 Lot# 10119333 Exp 07/13
- Recall started
- May 15, 2013
- Recall number
- D-740-2014
Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg…
- 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
- Reason
- Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
- Quantity
- 167,712/24-caplet packages
- Codes and lots
- Lot# 10117247 06/13 Lot# 10119336 07/13
- Recall started
- May 15, 2013
- Recall number
- D-741-2014
Theraflu Warming Relief…
- 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.
- Reason
- Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
- Quantity
- 98,024/8-caplet packages and 557,548/24-caplet packages
- Codes and lots
- 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 started
- May 15, 2013
- Recall number
- D-742-2014
Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold…
- 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.
- Reason
- Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
- Quantity
- 3,768/8-caplet packages and 300,580/24-caplet packages
- Codes and lots
- 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 started
- May 15, 2013
- Recall number
- D-743-2014
Excedrin…
- 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.
- Reason
- Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
- Quantity
- 2,978,000/2-caplet packages
- Codes and lots
- Lot# 10118234 Exp 05/13 Lot# 10120254 Exp 05/13 Lot# 10123513 Exp 08/13 Lot#10125262 Exp 09/13
- Recall started
- May 15, 2013
- Recall number
- D-744-2014
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement reports, recall numbers D-738-2014, D-739-2014, D-740-2014, D-741-2014, D-742-2014, D-743-2014, D-744-2014. The agency record governs; check it and the company before acting.