Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01

Recall Number: D-1046-2016

Firm: Sandoz, Inc

Classification: Class III

Status: Terminated

Report Date: 20160629

Initiation Date: 20160502

Termination Date: 20170817

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

Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01