FDA Drug recall D-0447-2017
Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc
- FDA Drug
- Class II
- terminated
- Published 2017-02-01
On 2017-02-01 the FDA classified a Class II recall of Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc by Cambrex Charles City, citing presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0447-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-20 |
| Published | 2017-02-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Cambrex Charles City |
| Distribution | MN |
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
Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
Identifiers
| code_info | Code 1661911; Batch 1340; Exp. 03/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0447-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.