Why it was recalled
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
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
Lot numbers, UPCs & expiration codes
Lot Number AE7363A, exp 06/30/2019
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0432-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 2, 2016
- FDA report date
- Jan 25, 2017
- Quantity
- 4,520 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shire PLC
Original FDA data
Every field from FDA enforcement report D-0432-2017, exactly as published.
Show all FDA fields
- City
- Lexington
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 75880
- Address
- 300 Shire Way
- Code information
- Lot Number AE7363A, exp 06/30/2019
- Postal code
- 02421-2101
- Report date
- Jan 25, 2017
- Product type
- Drugs
- Recall number
- D-0432-2017
- Classification
- Class III
- Recalling firm
- Shire PLC
- Product quantity
- 4,520 bottles
- Termination date
- Jun 1, 2018
- Reason for recall
- Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Dec 2, 2016
- Center classification date
- Jan 17, 2017