The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0533-2016·Announced 2016-01-06

Walgreens Recalls Cefazolin Infusion Bags Due to Sterility Concerns

Walgreens Infusion Services is recalling specific Cefazolin infusion bags compounded 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, and the hazard involves a lack of assurance of sterility for an injectable drug, which poses a significant risk of serious injury or hospitalization (e.g., sepsis), meeting the criteria for a Severe rating.

Plain-English summary

Walgreens Infusion Services is recalling 34 Accuflo bags of Cefazolin (1g/NS 25 mL, 2g/NS 25 mL, and 8g/NS 275 mL) that were compounded by Option Care 148 in San Antonio, Texas. The recall was initiated because of a lack of assurance of sterility for these prescription-only products.

The affected products were distributed in Texas. The source text does not specify the exact lot numbers, stating only that all lots within expiry are affected. No specific dates or additional distribution details are provided in the notice.

Consumers and healthcare providers should stop using the affected Cefazolin infusion bags and contact their healthcare provider or Walgreens Infusion Services for further instructions or a replacement.

The recalled product

Product
Cefazolin in Accuflo bags, a) 1g/NS 25 mL, b) 2g/NS 25 mL, c) 8g/NS 275 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Lack
Manufacturer
Walgreens Infusion Services
Category
Drug — Antibiotic Infusion
Hazard
Affected units
34

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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