Drug product
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
Product summary
- Firm
- Shire PLC
- Event
- Event 75880
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,520 bottles
- Official record key
drug-enforcement:D-0432-2017
Official wording
Reason: Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Code information: Lot Number AE7363A, exp 06/30/2019
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets