Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Servic...

FDA Recall #D-0125-2017 — Class II — October 12, 2016

Recall #D-0125-2017 Date: October 12, 2016 Classification: Class II Status: Terminated

Product Description

Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.

Reason for Recall

Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.

Recalling Firm

Pharmedium Services, LLC — Lake Forest, IL

Classification

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

Product Type

Drugs

Product Quantity

1550 units

Distribution

Nationwide

Code Information

Lot #: 162790012M, Exp. 1/3/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated