# FDA recall D-0447-2017

> **Cambrex Charles City Inc** · Class II · drug recall initiated 2014-05-20.

## 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.

## Distribution

Product distributed solely to the state of Minnesota.

## Key facts

- **Recall number:** D-0447-2017
- **Recalling firm:** Cambrex Charles City Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-05-20
- **Report date:** 2017-02-01
- **Termination date:** 2017-03-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Charles City, IA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0447-2017

## Citation

> AI Analytics. FDA recall D-0447-2017. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0447-2017. Source: US FDA. Licensed CC0.

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