Multi-event December 2021 FDA Recall Drug by Teva Pharmaceuticals Usa

This Multi-event Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on December 31, 2021 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in Methylprednisolone, TN Norepinephrine BItartrate - MS, OH and the recall is currently terminated.

Reported Recall Events

D-0371-2022 TERMINATED D-0370-2022 TERMINATED

Recall Number: D-0371-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-31-2021
Reported
01-19-2022
Quantity
11,450 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89326
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.
Methylprednisolone, TN Norepinephrine BItartrate - MS, OH
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03.

Batch or Lot Expiration Information

Lot# 100020800, exp 07/2022

Recall Number: D-0370-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-31-2021
Reported
01-19-2022
Quantity
7,400 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89326
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.
Methylprednisolone, TN Norepinephrine BItartrate - MS, OH
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2024
Product Description About Product Description
Full technical description of the product.
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons.

Batch or Lot Expiration Information

Lot# 100022393, exp 09/2022