May 2022 FDA Recall Drug by Teva Pharmaceuticals Usa Inc
D-0988-2022 - Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing

This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa Inc on May 18, 2022 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 Nationwide and the recall is currently terminated.

Recall Number: D-0988-2022

Reason for Recall
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Initiated
05-18-2022
Reported
06-15-2022
Quantity
3109 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90239
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.
Teva Pharmaceuticals USA 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.
Product was distributed nationwide in the US Market
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-08-2023
Product Description About Product Description
Full technical description of the product.
Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-1501-01

Batch or Lot Expiration Information

Lot# :100022404, Exp Date 10/2022
Lot# :100023333, Exp Dat 12/2022