FDA Drug recall D-1045-2016
Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc.,…
- FDA Drug
- Class III
- terminated
- Published 2016-06-29
On 2016-06-29 the FDA classified a Class III recall of Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc.,… by Sandoz, citing failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1045-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-05-02 |
| Published | 2016-06-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sandoz |
| Distribution | US |
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
Reason
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Identifiers
| code_info | Lot #s: EN3846, Exp 08/2016; FA4809, Exp 2/2017, FW3654 , Exp11/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1045-2016%22
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