Why it was recalled
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Product description
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-743-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 15, 2013
- FDA report date
- Jan 22, 2014
- Quantity
- 3,768/8-caplet packages and 300,580/24-caplet packages
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Consumer Health
Original FDA data
Every field from FDA enforcement report D-743-2014, exactly as published.
Show all FDA fields
- City
- Lincoln
- State
- NE
- Status
- Terminated
- Country
- United States
- Event ID
- 65181
- Address
- 10401 Hwy 6
- 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
- Postal code
- 68517-9626
- Report date
- Jan 22, 2014
- Product type
- Drugs
- Recall number
- D-743-2014
- Classification
- Class III
- Recalling firm
- Novartis Consumer Health
- Product quantity
- 3,768/8-caplet packages and 300,580/24-caplet packages
- Termination date
- Nov 4, 2014
- Reason for recall
- Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
- Recall initiation date
- May 15, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 16, 2014