EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx,...

FDA Recall #D-0308-2022 — Class II — November 12, 2021

Recall #D-0308-2022 Date: November 12, 2021 Classification: Class II Status: Terminated

Product Description

EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-227-01.

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

26,928 bags

Distribution

U.S.A. Nationwide

Code Information

S21254/BWZ 22-Nov-21 S21263/BXG 30-Nov-21 S21333/BZT 11-Jan-22 S21398/CCG 19-Feb-22

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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