Unlikely to cause harm — often a labeling or packaging issue.
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
| Distributed by / for | Sandoz Inc., Princeton, NJ 08540, Product of Spain |
| NDC | 0781-2248-01 |
| Full product label | 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 |
| Recalling firm | Sandoz, Inc |
| Distribution | Nationwide |
| Quantity | 78,606 bottles |
| Recall initiated | 2016-05-02 |
| Report date | 2016-06-29 |
| Recall completed | 2017-08-17 |
| Recall number | D-1045-2016 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Princeton NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗