Recalls / Class III
Class IIID-0432-2017
Product
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81
- Brand name
- Pentasa
- Generic name
- Mesalamine
- Active ingredient
- Mesalamine
- Route
- Oral
- NDCs
- 54092-189, 54092-191
- FDA application
- NDA020049
- Affected lot / code info
- Lot Number AE7363A, exp 06/30/2019
Why it was recalled
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Recalling firm
- Firm
- Shire PLC
- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Type
- Voluntary: Firm initiated
- Address
- 300 Shire Way, Lexington, Massachusetts 02421-2101
Distribution
- Quantity
- 4,520 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-12-02
- FDA classified
- 2017-01-17
- Posted by FDA
- 2017-01-25
- Terminated
- 2018-06-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0432-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.