PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 1, 2017 Initiated: May 20, 2014 #D-0447-2017

Product Description

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.

Details

Recalling Firm
Cambrex Charles City Inc
Units Affected
2351.12 pound container
Distribution
Product distributed solely to the state of Minnesota.
Location
Charles City, IA

Frequently Asked Questions

What product 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. Recalled by Cambrex Charles City Inc. Units affected: 2351.12 pound container.
Why was this product recalled?
Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 1, 2017. Severity: Moderate. Recall number: D-0447-2017.