Drug 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.
D-843-2013
Product summary
- Event
- Event 65422
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 4,178,000 pouches; b) 101,300 boxes and c) & d) 38,235 pouches and boxes (combined)
- Official record key
drug-enforcement:D-843-2013
Official wording
Reason: Defective container: products are packaged in pouches which may not have been fully sealed
Code information: 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
Distribution pattern: Nationwide, Puerto Rico, Brazil and Panama
Derived failure modes
-
Unknown
Defective container: products are packaged in pouches which may not have been fully sealed