Drug product
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
D-1045-2016
Product summary
- Firm
- Sandoz, Inc
- Event
- Event 74068
- Status
- Terminated
- Classification
- Class III
- Quantity
- 78,606 bottles
- Official record key
drug-enforcement:D-1045-2016
Official wording
Reason: Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Code information: Lot #s: EN3846, Exp 08/2016; FA4809, Exp 2/2017, FW3654 , Exp11/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification