Status
Terminated
Drug Enforcement D-846-2013
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
- Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis Consumer Health S.A., Brazil, for Novartis de Venezuela. The foreign packaging do not have NDC number This product was only distributed to Novartis Brazil by the recalling firm
- Product quantity
- 472,000 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-846-2013
- Event ID
- 65422
- Recall initiation date
- June 6, 2013
- Center classification date
- August 6, 2013
- Code info
- Lot # 10121996, Exp 7/13
- More code info
- —