April 2019 FDA Recall Drug by Johnson Matthey Inc.
D-1252-2019 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Johnson Matthey Inc. on April 2, 2019 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1252-2019

Reason for Recall
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
Initiated
04-02-2019
Reported
04-24-2019
Quantity
416.95 g glass container

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82618
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to one manufacturer in Morgantown, WV who may have manufactured the product into finished product and further distribute to the retail level Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-10-2020
Product Description About Product Description
Full technical description of the product.
Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass container, Rx ONLY, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742.

Batch or Lot Expiration Information

Lot# : B1319-170101