Agency classClass IIOur severity:Severe FDA (Drugs)·D-0556-2016·Announced 2016-01-06

Walgreens Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

Walgreens Infusion Services is recalling 43 bags of 0.9% Sodium Chloride injection 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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential hospitalization or significant injury risks associated with sterility failures in injectable products.

Plain-English summary

Walgreens Infusion Services is recalling 43 bags of 0.9% Sodium Chloride injection, available in 500 mL, 1000 mL, and 2000 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 of distribution or illness reports are provided in the source material.

Consumers and healthcare providers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on return or disposal. This recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: 0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Manufacturer: Walgreens Infusion Services
Category: Drug — Injectable Solution
Hazard: sterility-failure
infection-risk
Affected units: 43

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 failure