FDA recall D-0447-2017

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

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

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