Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81
Reported: January 25, 2017 Initiated: December 2, 2016 #D-0432-2017
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
Details
- Recalling Firm
- Shire PLC
- Units Affected
- 4,520 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Lexington, MA
Frequently Asked Questions
What product was recalled? ▼
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81. Recalled by Shire PLC. Units affected: 4,520 bottles.
Why was this product recalled? ▼
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 25, 2017. Severity: Low. Recall number: D-0432-2017.
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