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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Novartis Consumer Health
- Reason for Recall:
- Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-743-2014
Related Recalls
The products are being recalled due to the receipt of a relatively high number of consumer complaints.
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.