Walgreens Recalls 3-in-1 TPN Formula Bags Due to Sterility Concerns
Walgreens Infusion Services is recalling 87 bags of 3-in-1 TPN formula in Texas due to a lack of assurance of sterility.
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 involves a lack of assurance of sterility in a parenteral nutrition product, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
Walgreens Infusion Services is recalling 87 bags of 3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only. The product was compounded by Option Care 148 in San Antonio, Texas. The recall is being conducted because of a lack of assurance of sterility.
The affected product is distributed in Texas. The recall covers all lots within the expiry date. The FDA has classified this recall as Class II.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to proceed.
The recalled product
- Product
- 3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
- Manufacturer
- Walgreens Infusion Services
- Category
- Drug — Parenteral Nutrition
- Affected units
- 87
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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