The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0544-2016·Announced 2016-01-06

Walgreens Recalls Sodium Ascorbate Syringes Due to Sterility Concerns

Walgreens Infusion Services is recalling compounded Sodium Ascorbate (Vitamin C) syringes 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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving potential hospitalization or significant injury risks associated with sterility failures in injectable drugs.

Plain-English summary

Walgreens Infusion Services is recalling 30 syringes of Sodium Ascorbate (Vitamin C) in various concentrations (500 mg/1 mL, 1000 mg/2 mL, and 800 mg/1.6 mL). The product is compounded by Option Care 148 in San Antonio, Texas, and was distributed in Texas.

The recall was initiated because of a lack of assurance of sterility. The source text does not specify which lot numbers are affected, stating only that all lots within expiry are included. No specific dates of distribution or illness reports are provided in the source material.

Consumers who have these syringes should stop using them and contact their healthcare provider or the recalling firm for further instructions. The product is prescription-only.

The recalled product

Product
Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL c) 800 mg/1.6 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Manufacturer
Walgreens Infusion Services
Category
Drug — Compounded Injectable
Hazard
Affected units
30

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 →

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