The Recall Desk
SevereFDA (Drugs)·D-0534-2016·Announced 2016-01-06

Walgreens Recalls Dextrose and Sodium Chloride Infusion Bags Due to Sterility Concerns

Walgreens Infusion Services is recalling Dextrose 5% and 0.45% Sodium Chloride with KCl 20 mEq 1000 mL bags in Texas due to a lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in infusion products) are categorized as Severe (Score 4), particularly when structural or significant injury risks are implied by the lack of sterility assurance.

Plain-English summary

Walgreens Infusion Services is recalling Dextrose 5% and 0.45% Sodium Chloride with KCl 20 mEq 1000 mL bags. The product is compounded by Option Care 148 in San Antonio, Texas, and is available by prescription only. The recall was initiated because of a lack of assurance of sterility.

The affected product is distributed in Texas. The recall includes all lots within the expiration date. 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.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions or a replacement.

The recalled product

Product
Dextrose 5% and 0.45% Sodium Chloride with KCl 20 mEq 1000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Affected units
1

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 →