FDAFDA · Food and drugs·Recall number D-1045-2016
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
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 #s: EN3846, Exp 08/2016; FA4809, Exp 2/2017, FW3654 , Exp11/2017
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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