February 2020 FDA Recall Mesalamine by Teva Pharmaceuticals Usa
D-0862-2020 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on February 20, 2020 for the product Mesalamine. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0862-2020

Reason for Recall
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Initiated
02-20-2020
Reported
03-11-2020
Quantity
3,695 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85017
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 0591-2245-22.

Batch or Lot Expiration Information

Lot# : 1342500A, Exp 10/2020

Affected Packages Involved in this Recall

0591-2245-22 Mesalamine