Pentasa recall
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC…
Why was Pentasa recalled?
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number AE7363A, exp 06/30/2019
- Product
- Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC…
- Recalling firm
- Shire PLC
- Quantity
- 4,520 bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- January 25, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)