Drug recall
Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540…
FDA recall event 64936 · Class II · Sandoz Incorporated
Key facts
| Event ID | 64936 |
|---|---|
| Recall numbers | D-268-2013 |
| Recalling firm | Sandoz Incorporated |
| Product type | Drugs |
| Products | Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh. |
| Initiation date | Apr 18, 2013 |
| Report date | May 1, 2013 |
| Termination date | Feb 26, 2014 |
| City | Broomfield |
| State | CO |
| Country | United States |
| FEI number | 1717759 |
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: