PlainRecalls
FDA Drug Moderate Class II Terminated

IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Reported: January 6, 2016 Initiated: November 10, 2015 #D-0540-2016

Product Description

IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
1 bag
Distribution
Texas
Location
San Antonio, TX

Frequently Asked Questions

What product was recalled?
IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045. Recalled by Walgreens Infusion Services. Units affected: 1 bag.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on January 6, 2016. Severity: Moderate. Recall number: D-0540-2016.