Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag,...

FDA Recall #D-0934-2023 — Class II — July 7, 2023

Recall #D-0934-2023 Date: July 7, 2023 Classification: Class II Status: Terminated

Product Description

Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01.

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

SterRx, LLC — Plattsburgh, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2,088 bags

Distribution

Nationwide in the USA

Code Information

Lot #: 490100, Exp 27-Jul-23

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated