Mesalamine — Class II drug recall D-0447-2017
Terminated recall by Cambrex Charles City Inc, reported 2017-02-01, distributed in MN. Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was
| Recall number | D-0447-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cambrex Charles City Inc, Charles City, IA, United States |
| Recall initiated | 2014-05-20 |
| Classified | 2017-01-26 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2017-03-09 |
| Distributed | MN |
| Quantity | 2,351.12 pounds |
| Reason classes | chemical contamination, specification failure |
| Lot numbers | 03/17, 1340 |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0447-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.