The Recall Desk
HighFDA (Drugs)·D-0553-2016·Announced 2016-01-06

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.

What this means for you

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
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.

See all 33 products in this recall →