Drug recall
Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh…
FDA recall event 74068 · Class III · Sandoz, Inc
Key facts
| Event ID | 74068 |
|---|---|
| Recall numbers | D-1045-2016, D-1046-2016 |
| Recalling firm | Sandoz, Inc |
| Product type | Drugs |
| Products | 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, 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 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing. |
| Initiation date | May 2, 2016 |
| Report date | Jun 29, 2016 |
| Termination date | Aug 17, 2017 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3006697677 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: