FDA recall D-741-2014

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2013-05-15

Report date

2014-01-22

Termination date

2014-11-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lincoln, NE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-741-2014