Tobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 7823...

FDA Recall #D-0553-2016 — Class II — November 10, 2015

Recall #D-0553-2016 Date: November 10, 2015 Classification: Class II Status: Terminated

Product Description

Tobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Walgreens Infusion Services — San Antonio, TX

Classification

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

Product Type

Drugs

Product Quantity

7 Accuflo bags

Distribution

Texas

Code Information

All lots within expiry.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated