FDA recall D-0371-2022

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.

Reason for recall

Lack of Assurance of Sterility

Distribution

Methylprednisolone, TN Norepinephrine BItartrate - MS, OH

Key facts

Status

Terminated

Initiation date

2021-12-31

Report date

2022-01-19

Termination date

2024-06-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0371-2022