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

Agency Publication Date: June 20, 2016

Affected Products

Product: 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

Lot #s: EN3846, Exp 08/2016; FA4809, Exp 2/2017, FW3654 , Exp11/2017

Product: 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

Lot #: EN0389, EP0473, Exp. 8/2016 ; FA4834, FN2602, Exp. 2/2017; FW3646 , Exp.11/2017

Lot Numbers:

EN0389

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 74068

Status: Resolved

Manufacturer: Sandoz, Inc

Manufactured In: United States

Units Affected: 78,606 bottles

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Sources: FDA iRES · Raw API Response

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