May 2014 FDA Recall Drug by Cambrex Charles City Inc
D-0447-2017 - Presence of Particulate Matter

This Class II drug recall was voluntarily initiated by Cambrex Charles City Inc on May 20, 2014 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed in Product distributed solely to the state of Minnesota. and the recall is currently terminated.

Recall Number: D-0447-2017

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.
Initiated
05-20-2014
Reported
02-01-2017
Quantity
2351.12 pound container

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76166
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cambrex Charles City Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product distributed solely to the state of Minnesota.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-09-2017
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

Batch# Code 1661911; Batch 1340; Exp. 03/17