Drug recall
Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE…
FDA recall event 76166 · Class II · Cambrex Charles City Inc
Key facts
| Event ID | 76166 |
|---|---|
| Recall numbers | D-0447-2017 |
| Recalling firm | Cambrex Charles City Inc |
| Product type | Drugs |
| Products | Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside Poly-lined cardboard drums. Net weight 40 kg |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product. |
| Initiation date | May 20, 2014 |
| Report date | Feb 1, 2017 |
| Termination date | Mar 9, 2017 |
| City | Charles City |
| State | IA |
| Country | United States |
| FEI number | 1000119390 |
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 · Source date: