Reported Jan 25, 2017 · Terminated
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc.,…
Shire PLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shire PLC · 300 Shire Way · Lexington, MA · 02421-2101
Is this the product you have?
- Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81
- Lot codes and dates
Lot Number AE7363Aexp 06/30/2019
- Amount recalled
- 4,520 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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