Walgreens Recalls IVIG Gamunex Bags Due to Sterility Concerns
Walgreens Infusion Services is recalling IVIG Gamunex bags in Texas because the sterility of the product cannot be assured.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 product, which poses a significant risk of infection or serious injury.
Plain-English summary
Walgreens Infusion Services is recalling IVIG Gamunex 40 gm (400 mL) bags, which are prescription-only compounded by Option Care 148 in San Antonio, Texas. The recall is being conducted because there is a lack of assurance of the sterility of the product.
The affected product is distributed in Texas. The recall includes all lots within their expiry dates. No specific lot numbers or dates are provided in the source text.
Consumers and healthcare providers should stop using the affected IVIG Gamunex bags and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
- Manufacturer
- Walgreens Infusion Services
- Category
- Drug — Biologic / IVIG
- Affected units
- 1
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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