Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported February 1, 2017
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
Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
Cambrex Charles City Inc recalled Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in … — a moderate-severity action.
Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in … was recalled by Cambrex Charles City Inc in February 1, 2017. Reason: Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was…. Check the official notice for the remedy. Verify recall #D-0447-2017 with the FDA Drug before acting.
The recall
Cambrex Charles City Inc issued this moderate-severity FDA Drug recall — Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was….
- Moderate
- severity level
- Class II
- classification
- February 1, 2017
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0447-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0447-2017) was formally reported on February 1, 2017, with the manufacturer initiating the action on May 20, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Cambrex Charles City Inc is listed as the recalling firm, operating out of Charles City, IA. Federal records list the affected scope as 2351.12 pound container.
The documented reason for this recall is: Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product. Distribution data in the federal record shows the product reached: Product distributed solely to the state of Minnesota.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 4 from FDA Drug — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Vehicles recalls over time
Where this recall sits in its category — 9,301 vehicles recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
2351.12 pound container
Related Recalls
6
4 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0447-2017 |
| Date reported | February 1, 2017 |
| Date initiated | May 20, 2014 |
| Recalling firm | Cambrex Charles City Inc |
| Firm location | Charles City, IA |
| Affected scope | 2351.12 pound container |
| Distribution | Product distributed solely to the state of Minnesota. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0447-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cambrex Charles City Inc. Units affected: 2351.12 pound container.
Why was this product recalled? ▼
Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 1, 2017. Severity: Moderate. Recall number: D-0447-2017.
Where was the recalled product distributed? ▼
Distribution: Product distributed solely to the state of Minnesota..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0447-2017) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Drug, reported February 1, 2017.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.