EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx,...

FDA Recall #D-0311-2022 — Class II — November 12, 2021

Recall #D-0311-2022 Date: November 12, 2021 Classification: Class II Status: Terminated

Product Description

EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-627-01.

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

684 bags

Distribution

U.S.A. Nationwide

Code Information

S21335/BZV

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated