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.
Reported: January 22, 2014 Initiated: May 15, 2013 #D-742-2014
Product Description
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 for Recall
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Details
- Recalling Firm
- Novartis Consumer Health
- Units Affected
- 98,024/8-caplet packages and 557,548/24-caplet packages
- Distribution
- Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
- Location
- Lincoln, NE
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Novartis Consumer Health. Units affected: 98,024/8-caplet packages and 557,548/24-caplet packages.
Why was this product recalled? ▼
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 22, 2014. Severity: Low. Recall number: D-742-2014.
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