FDA recall D-1046-2016

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-05-02

Report date

2016-06-29

Termination date

2017-08-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1046-2016