Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Specific volumes. Mixed ...

FDA Recall #D-0611-2020 — Class II — May 30, 2019

Recall #D-0611-2020 Date: May 30, 2019 Classification: Class II Status: Terminated

Product Description

Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Services,3908 TENN.AVE. CHATT,TN37409

Reason for Recall

Lack of sterility assurance.

Recalling Firm

Surgery Pharmacy Services Inc — Chattanooga, TN

Classification

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

Product Type

Drugs

Product Quantity

84 bags

Distribution

Distributed in GA, TN

Code Information

RX numbers from 311976 to 314888

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated