Drug recall D-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
Reason for recall
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Lots and codes
Lot Number AE7363A, exp 06/30/2019
Recall details
- Recalling firm
- Shire PLC, Lexington, MA
- Quantity
- 4,520 bottles
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 2, 2016
- Terminated
- June 1, 2018
Related products
- Pentasa – drug information
- NDC 54092-189 Pentasa · Mesalamine 250 mg/1 · Takeda Pharmaceuticals America, Inc.
- NDC 54092-191 Pentasa · Mesalamine 500 mg/1 · Takeda Pharmaceuticals America, Inc.