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
Reported: June 29, 2016 Initiated: May 2, 2016 #D-1045-2016
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Details
- Recalling Firm
- Sandoz, Inc
- Units Affected
- 78,606 bottles
- Distribution
- Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sandoz, Inc. Units affected: 78,606 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 29, 2016. Severity: Low. Recall number: D-1045-2016.
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