D-0432-2017 Class III Terminated
FDA drug recall D-0432-2017 was initiated by Shire PLC on December 2, 2016 and is designated Class III. Reason for recall: Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules The recall status is terminated (terminated June 1, 2018). Affected quantity: 4,520 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 25, 2017
- Initiation Date
- December 2, 2016
- Termination Date
- June 1, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,520 bottles
Product Description
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
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot Number AE7363A, exp 06/30/2019