Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per...
FDA Recall #D-0371-2022 — Class II — December 31, 2021
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
Teva Pharmaceuticals USA — Parsippany, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
11,450 vials
Distribution
Methylprednisolone, TN Norepinephrine BItartrate - MS, OH
Code Information
Lot # 100020800, exp 07/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated