Class II · Moderate risk
Mesalamine Extended-Release Capsules
Failed Dissolution Specifications: Out of specification for dissolution.
Pentasa (mesalamine)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81
Affected NDC
54092-0189-81
Compare with the code on your package — it is the most precise check available.
Drug: Mesalamine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Pentasa mesalamine NDC 54092-0189 |
250 mg/1 | Capsule Oral |
Takeda Pharmaceuticals America, Inc. | Rx |
- Recalling firm
- Shire PLC
- NDC code
- 54092-189-81
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0432-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Mesalamine recalls
See all
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Other recalls by Shire PLC
All 2016 recalls
Class II · Moderate risk
Kalbitor (ecallantide)
Presence of Particulate Matter: Glass
Class III · Low risk
Vyvanse (lisdexamfetamine dimesylate)
Presence of Foreign Tablets/Capsules
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