Tobramycin Infusion Bags Recalled Due to Sterility Assurance Concerns
Walgreens Infusion Services is recalling Tobramycin 620 mg/NS 100 mL Accuflo bags 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 involves a risk-of-harm product (sterility issue in an infusion) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Walgreens Infusion Services is recalling seven Accuflo bags of Tobramycin 620 mg/NS 100 mL, prescription only. The product was compounded by Option Care 148 in San Antonio, Texas, and distributed in Texas. All lots within the expiry date are affected.
The recall was initiated due to a lack of assurance of sterility. The source text does not report any specific illnesses, injuries, or deaths associated with this product.
Healthcare providers and patients who have received this product should contact their healthcare provider for further instructions. Consumers should not use the recalled product.
The recalled product
- Product
- Tobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
- Manufacturer
- Walgreens Infusion Services
- Category
- Drug — Infusion
- Hazard
- Affected units
- 7
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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