Drug recall
Potassium Citrate Tablets, 540 mg (5 mEq per tablet), 100-count tablets per bottle, Rx Only, Distributed by…
FDA recall event 60501 · Class III · Upsher Smith Laboratories, Inc.
Key facts
| Event ID | 60501 |
|---|---|
| Recall numbers | D-867-2012 |
| Recalling firm | Upsher Smith Laboratories, Inc. |
| Product type | Drugs |
| Products | Potassium Citrate Tablets, 540 mg (5 mEq per tablet), 100-count tablets per bottle, Rx Only, Distributed by Upsher-Smith Laboratories, Inc.,; Minneapolis, MN 55447; NDC 0245-0070-11, UPC 3… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed USP Dissolution Test Requirements: Upsher-Smith Laboratories is recalling one lot of Potassium Citrate Tablets because the product failed to meet specifications for dissolution at the 9-month… |
| Initiation date | Nov 14, 2011 |
| Termination date | Jul 13, 2012 |
| City | Maple Grove |
| State | MN |
| Country | United States |
| FEI number | 3004106442 |
At a glance
- 1–9 Products in this recall
- 10–99 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