FDAFDA · Food and drugs·Recall number D-1046-2016
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
Published June 29, 2016 · Recall initiated: May 2, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sandoz, Inc
- Distributor
- Nationwide
- Lot
- Lot #: EN0389, EP0473, Exp. 8/2016 ; FA4834, FN2602, Exp. 2/2017; FW3646 , Exp.11/2017
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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