Recalls / Class II

Class IID-843-2013

Product

Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes of 50/2-ct packages, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2030 02 Foreign packaging: c) Parsel Forte and d) Cibalenaa (250 mg Acetaminophen, 250 mg Aspirin, 65 mg Caffeine), boxes of 48/4-ct pouches Foreign packaging do not have NDC numbers.

Affected lot / code info

Lot #s a) 10120190, Exp 6/13 and 10121628, Exp 7/13; Lot #s b) 10115658, Exp 5/13; 10116807, Exp 5/13; 10121630, Exp 7/13 and 10125253, Exp 9/13 Foreign Lot #s c) 10120192, Exp 7/13; d)10120272, Exp 7/13, 10121528 Exp 7/13 and 10121958 Exp 8/13

Why it was recalled

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

Recalling firm

Firm

Novartis Consumer Health

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

10401 Hwy 6, N/A, Lincoln, Nebraska 68517-9626

Distribution

Quantity

a) 4,178,000 pouches; b) 101,300 boxes and c) & d) 38,235 pouches and boxes (combined)

Distribution pattern

Nationwide, Puerto Rico, Brazil and Panama

Timeline

Recall initiated

2013-06-06

FDA classified

2013-08-06

Posted by FDA

2013-08-14

Terminated

2014-11-04

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-843-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.