Status
Terminated
Drug Enforcement D-843-2013
Defective container: products are packaged in pouches which may not have been fully sealed
Classification
Class II
Report Date
August 14, 2013
Termination Date
November 4, 2014
Product Information
- Product description
- 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.
- Product quantity
- a) 4,178,000 pouches; b) 101,300 boxes and c) & d) 38,235 pouches and boxes (combined)
- 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-843-2013
- Event ID
- 65422
- Recall initiation date
- June 6, 2013
- Center classification date
- August 6, 2013
- 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
- More code info
- —