Agency classClass IIOur severity:Severe FDA (Drugs)·D-0555-2016·Announced 2016-01-06

Walgreens Infusion Services Recalls Dextrose and Sodium Chloride Injection Bags

Walgreens Infusion Services is recalling 9 bags of Dextrose 5% and 0.9% Sodium Chloride injection 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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with hospitalization reports or significant injury/property-damage reports are Severe. While the source does not explicitly mention hospitalizations, the 'Lack of Assurance of Sterility' for an IV injection is a significant hazard that aligns with the Severe criteria for Class II recalls involving potential serious harm.

Plain-English summary

Walgreens Infusion Services is recalling 9 bags of Dextrose 5% and 0.9% Sodium Chloride injection, available in 1000 mL and 3000 mL sizes. The product was compounded by Option Care 148 in San Antonio, Texas, and distributed within Texas. The recall is being conducted because there is a lack of assurance of sterility for the affected lots.

The affected product is prescription-only (Rx Only). The source text does not specify the exact lot numbers, stating only that all lots are within expiry. No specific dates or additional distribution details are provided in the notice.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II.

The recalled product

Product: Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL, b) 3000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Manufacturer: Walgreens Infusion Services
Category: Drug — Infusion Solution
Hazard: sterility
Affected units: 9

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 →

Same manufacturer · Walgreens Infusion Services

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Same hazard · sterility