Drug 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
D-1046-2016
Product summary
- Firm
- Sandoz, Inc
- Event
- Event 74068
- Status
- Terminated
- Classification
- Class III
- Quantity
- N/A
- Official record key
drug-enforcement:D-1046-2016
Official wording
Reason: Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Code information: Lot #: EN0389, EP0473, Exp. 8/2016 ; FA4834, FN2602, Exp. 2/2017; FW3646 , Exp.11/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification