Cambrex Recalls Mesalamine API Due to Stainless Steel Particulate Matter
Cambrex Charles City Inc is recalling Mesalamine API due to the presence of stainless steel particulate matter detected in the finished product.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is the presence of particulate matter (stainless steel) in a pharmaceutical API, which is a quality defect but does not meet the criteria for Class I (death/serious injury) or Class III (unlikely to cause adverse health consequences).
Plain-English summary
Cambrex Charles City Inc is recalling Mesalamine, U.S.P. [CAS 89-57-6] due to the presence of particulate matter. The recall involves product packaged in double lined PE liners inside Poly-lined cardboard drums with a net weight of 40 kg.
The recall was initiated because stainless steel from a chemical reactor dissolved into the API solution and was detected in the finished product. The specific product code is 1661911, Batch 1340, with an expiration date of 03/17.
The product was distributed solely to the state of Minnesota. Consumers and healthcare providers should stop using the affected product and contact their supplier or the recalling firm for further instructions.
The recalled product
- 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
- Manufacturer
- Cambrex Charles City Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Code 1661911
- Batch 1340
- Exp. 03/17
Distribution
Distributed in 1 state:
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