Class III
Terminated
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81
This recall has been terminated (originally issued January 25, 2017).
- Company
- Shire Plc
- Recall Initiated
- December 2, 2016
- Posted
- January 25, 2017
- Recall Number
- D-0432-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4,520 bottles
- Firm Location
- Lexington, MA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot Number AE7363A, exp 06/30/2019
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