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IVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm, Rx Only, Compounded by Option Care 14...

FDA Recall #D-0547-2016 — Class II — November 10, 2015

Recall #D-0547-2016 Date: November 10, 2015 Classification: Class II Status: Terminated

Product Description

IVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm, 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

5 bags

Distribution

Texas

Code Information

All lots within expiry.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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