Agency classClass IIOur severity:Severe FDA (Drugs)·D-0535-2016·Announced 2016-01-06

Walgreens Infusion Services Recalls 0.9% NaCl Bags Due to Sterility Concerns

Walgreens Infusion Services is recalling 7 bags of 0.9% NaCl with Ca 4.65 meq 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, and the rubric specifies that FDA Class II recalls with hospitalization reports or significant injury/property-damage reports are Severe. While specific injury reports are not detailed in the provided text, the 'Lack of Assurance of Sterility' for an infusion product represents a significant risk of serious adverse health consequences, aligning with the Severe classification for high-risk medical products.

Plain-English summary

Walgreens Infusion Services is recalling seven bags of 0.9% NaCl 1000 mL with Ca 4.65 meq. The product is compounded by Option Care 148 in San Antonio, Texas, and was distributed in Texas. The recall is being conducted because of a lack of assurance of sterility.

The affected product is prescription-only. All lots within the expiry date are included in this recall. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the product.

The recalled product

Product: 0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Manufacturer: Walgreens Infusion Services
Category: Drug — Infusion Solution
Hazard: sterility
infection
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 →

Same manufacturer · Walgreens Infusion Services

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