FDA-Drug2016-06-29Class III

Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01

Sandoz, Inc
Hazard

Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.

Sold states
Nationwide
Affected count
78,606 bottles
Manufactured in
506 Carnegie Ctr Ste 400, N/A, Princeton, NJ, United States
Products
Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1045-2016

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