Reported Feb 1, 2017 · Terminated

Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside…

Cambrex Charles City Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cambrex Charles City Inc · 1205 11th St · Charles City, IA · 50616-3466

Is this the product you have?

  • 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
Lot codes and dates
    • Code 1661911
    • Batch 1340
    • Exp. 03/17
Amount recalled
2351.12 pound container

Where it was sold

Why it was recalled

Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 9, 2017 · Data as of Sep 19, 5:01 PM UTC

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