Drug recall
AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for…
FDA recall event 70503 · Class II · Qualitest Pharmaceuticals
Key facts
| Event ID | 70503 |
|---|---|
| Recall numbers | D-0397-2015 |
| Recalling firm | Qualitest Pharmaceuticals |
| Product type | Drugs |
| Products | AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed tablet specifications: One lot was found to contain oversized tablets. |
| Initiation date | Feb 13, 2015 |
| Report date | Mar 11, 2015 |
| Termination date | Jan 27, 2016 |
| City | Huntsville |
| State | AL |
| Country | United States |
| FEI number | 1000524784 |
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: