Walgreens Recalls IVIG Gammagard Injection Bags Due to Sterility Concerns
Walgreens Infusion Services is recalling five bags of IVIG Gammagard injection in Texas due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility for an intravenous injection, which poses a significant risk of serious injury or infection.
Plain-English summary
Walgreens Infusion Services is recalling five bags of IVIG Gammagard injection (13 gm, 20 gm, and 73 gm) in Texas. The recall was initiated because of a lack of assurance of sterility for the product.
The affected product is compounded by Option Care 148 in San Antonio, Texas. All lots within the expiry date are included in this recall. The product is prescription-only.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to return or dispose of the medication.
The recalled product
- Product
- 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
- Manufacturer
- Walgreens Infusion Services
- Category
- Drug — Biologic / Injection
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 33 recalled by Walgreens Infusion Services under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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