December 2016 FDA Recall Pentasa by Shire Plc
D-0432-2017 - Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
This Class III drug recall was voluntarily initiated by Shire Plc on December 2, 2016 for the product Pentasa. The FDA reported the reason for recall as presence of foreign tablets/capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0432-2017
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
12-02-2016
01-25-2017
4,520 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Shire PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
06-01-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81
Batch or Lot Expiration Information
Lot# Lot Number AE7363A, exp 06/30/2019
