Drug Enforcement D-741-2014

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

Status

Terminated

Classification

Class III

Report Date

January 22, 2014

Termination Date

November 4, 2014

Product Information

Product description
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
Product quantity
167,712/24-caplet packages
Reason for recall
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.

Location & Firm

Recalling firm
Novartis Consumer Health
Address
10401 Hwy 6

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-741-2014
Event ID
65181
Recall initiation date
May 15, 2013
Center classification date
January 16, 2014
Code info
Lot# 10117247 06/13 Lot# 10119336 07/13
More code info
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