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

FDA recall notice · announced February 1, 2017 · Cambrex Charles City

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Product distributed solely to the state of Minnesota.
Lot/code information: Code 1661911; Batch 1340; Exp. 03/17
Quantity: 2351.12 pound container
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.