Drug recall
Metoprolol Succinate Extended Release Tablets USP, 100mg, 100 count bottle, Rx only, NDC 0185-0283-01, Sandoz…
FDA recall event 49482 · Class II · Sandoz, Inc
Key facts
| Event ID | 49482 |
|---|---|
| Recall numbers | D-108-2009, D-109-2009, D-110-2009, D-111-2009 |
| Recalling firm | Sandoz, Inc |
| Product type | Drugs |
| Products | Metoprolol Succinate Extended Release Tablets USP, 100mg, 100 count bottle, Rx only, NDC 0185-0283-01, Sandoz Inc., Princeton, NJ, Metoprolol Succinate Extended Release Tablets USP, 200mg, 100 count bottle, Rx only, NDC 0185-0284-01, Sandoz Inc., Princeton, NJ, Metoprolol Succinate Extended Release Tablets USP, 25mg, 100 count (NDC 0185-0281-01) and 1000 count (NDC 0185-0281-10) bottles, Rx only, Sandoz Inc., Princeton, NJ, Metoprolol Succinate Extended Release Tablets USP, 50mg, 100 count (NDC 0185-0282-01) and 1000 count (NDC 0185-0282-10) bottles, Rx only, Sandoz Inc., Princeton, NJ |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Inadequate documentation and in-process controls such that product may not meet specifications through shelf life. |
| Initiation date | Sep 17, 2008 |
| Termination date | Feb 28, 2012 |
| 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