Drug recall
Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured…
FDA recall event 77117 · Class III · Sandoz Inc
Key facts
| Event ID | 77117 |
|---|---|
| Recall numbers | D-0868-2017 |
| Recalling firm | Sandoz Inc |
| Product type | Drugs |
| Products | Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-20 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Subpotent Drug; Clavulanic Acid |
| Initiation date | Apr 26, 2017 |
| Report date | Jun 7, 2017 |
| Termination date | Aug 19, 2019 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3011552892 |
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: