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Recall Observatory FDA recall evidence

Drug product

No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2070 02

D-845-2013

June 06, 2013

Class II

Product summary

Firm
Novartis Consumer Health
Event
Event 65422
Status
Terminated
Classification
Class II
Quantity
4,422,000 pouches
Official record key
drug-enforcement:D-845-2013

Official wording

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

Code information: Lot #s 10110263, Exp 2/14; 10114706, Exp 4/14; 10118209, Exp 5/14; 10120253, Exp 7/14; 10123520, Exp 8/14; 10095199, Exp 7/13; 10102536, 11/2013, 10103950, Exp 12/13

Distribution pattern: Nationwide, Puerto Rico, Brazil and Panama

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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