D-0447-2017 Class II Terminated
FDA drug recall D-0447-2017 was initiated by Cambrex Charles City Inc on May 20, 2014 and is designated Class II. 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. The recall status is terminated (terminated March 9, 2017). Affected quantity: 2351.12 pound container.
Recall Details
- Product Type
- Drugs
- Report Date
- February 1, 2017
- Initiation Date
- May 20, 2014
- Termination Date
- March 9, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2351.12 pound container
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.
Distribution Pattern
Product distributed solely to the state of Minnesota.
Code Information
Code 1661911; Batch 1340; Exp. 03/17