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Recall Observatory FDA recall evidence

Drug 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.

D-742-2014

May 15, 2013

Class III

Product summary

Firm
Novartis Consumer Health
Event
Event 65181
Status
Terminated
Classification
Class III
Quantity
98,024/8-caplet packages and 557,548/24-caplet packages
Official record key
drug-enforcement:D-742-2014

Official wording

Reason: Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

Code information: 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

Distribution pattern: Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing