September 2018 FDA Recall Drug by Teva Pharmaceuticals Usa
D-0244-2019 - Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on September 27, 2018 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications; out-of-specification results for impurities obtained during routine stability testing. The product was distributed in Product was distributed throughout the United States, including Hawaii and Puerto Rico. and the recall is currently terminated.

Recall Number: D-0244-2019

Reason for Recall
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Initiated
09-27-2018
Reported
11-21-2018
Quantity
1,362 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81120
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.
Product was distributed throughout the United States, including Hawaii and Puerto Rico.
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.
Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02

Batch or Lot Expiration Information

Lot# 31323147B, exp. date 01/2019