Walgreens Recalls Milrinone Infusion Bags Due to Sterility Concerns
Walgreens Infusion Services is recalling 19 bags of Milrinone 0.375 mcg/kg/min D5W 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility issue) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Walgreens Infusion Services is voluntarily recalling 19 bags of Milrinone 0.375 mcg/kg/min D5W. The affected products are prescription-only infusion bags in 365 mL, 400 mL, and 430 mL sizes. These products were compounded by Option Care 148 in San Antonio, Texas.
The recall was initiated due to a lack of assurance of sterility. The source text does not specify the exact cause of the sterility issue or report any illnesses or injuries associated with the use of these products.
The recalled products were distributed in Texas. Consumers and healthcare providers should stop using the affected bags and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- Milrinone 0.375 mcg/kg/min D5W bag a) 365 mL, b) 400 mL c) 430 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
- Manufacturer
- Walgreens Infusion Services
- Category
- Drug — Infusion
- Hazard
- Affected units
- 19
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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