Drug 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
D-0447-2017
Product summary
- Event
- Event 76166
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2351.12 pound container
- Official record key
drug-enforcement:D-0447-2017
Official wording
Reason: Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
Code information: Code 1661911; Batch 1340; Exp. 03/17
Distribution pattern: Product distributed solely to the state of Minnesota.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter