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

Recall date

May 20, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0447-2017

FDA classification

Class II

Brand / firm

Cambrex Charles City Inc

Sold / distributed

Product distributed solely to the state of Minnesota.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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