IVIG Gammagard injection bag recalled over sterility concerns
- Recall date
- November 10, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Walgreens Infusion Services recalls IVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm, Rx Only, Compounded by Option Care 148, San Antonio, TX 782…
- Recall number
- D-0547-2016
- FDA classification
- Class II
- Brand / firm
- Walgreens Infusion Services
- Sold / distributed
- Texas
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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