Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81

FDA recall notice · announced January 25, 2017 · Shire

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Reason for recall

Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot Number AE7363A, exp 06/30/2019
Quantity: 4,520 bottles
Status: Terminated
Products in this recall event:
- Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81 (D-0432-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.