Drug Enforcement D-844-2013

Defective container: products are packaged in pouches which may not have been fully sealed

Status

Terminated

Classification

Class II

Report Date

August 14, 2013

Termination Date

November 4, 2014

Product Information

Product description
Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 203 702 Foreign packaging: b) Excedrin Migrana (Acetaminophen 250 mg, Aspirin 250 mg and 65 mg Caffeine) 2-ct pouches. The foreign packaging do not have NDC numbers
Product quantity
10,624,000 pouches
Reason for recall
Defective container: products are packaged in pouches which may not have been fully sealed
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide, Puerto Rico, Brazil and Panama

Location & Firm

Recalling firm
Novartis Consumer Health
Address
10401 Hwy 6, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-844-2013
Event ID
65422
Recall initiation date
June 6, 2013
Center classification date
August 6, 2013
Code info
Lot # a) 10116809, Exp 5/13 Foreign: Lot #s b) 10115644 Exp 5/13; 10118226 Exp 5/13; 10118227 Exp 6/13; 10118228 Exp 6/13; 10121956 Exp 8/13 and 10121957 Exp 8/13
More code info