March 2018 FDA Recall Drug by Johnson Matthey Inc.
D-1077-2019 - Microbial Contamination of Non-Sterile Products

This Class II drug recall was voluntarily initiated by Johnson Matthey Inc. on March 5, 2018 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1077-2019

Reason for Recall
Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
Initiated
03-05-2018
Reported
04-10-2019
Quantity
169.976 kg

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82298
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.
Johnson Matthey Inc.
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 US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2021
Product Description About Product Description
Full technical description of the product.
Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742

Batch or Lot Expiration Information

Lot# B1414-160809, Retest Date AUG 2021