FDAFDA · Food and drugs·Recall number D-0432-2017
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81
Published January 25, 2017 · Recall initiated: December 2, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
What to do
Voluntary: Firm initiated
Recall details
- Brand
- PENTASA
- Manufacturer
- Shire PLC
- Distributor
- Nationwide and Puerto Rico
- UPC
- 0354092191123
- Lot
- Lot Number AE7363A, exp 06/30/2019
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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