Sandoz, Inc recalls Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distribu…

Recall date

May 2, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1046-2016

FDA classification

Class III

Brand / firm

Sandoz, Inc

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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