The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0528-2016·Announced 2016-01-06

Walgreens Recalls Vancomycin Injection Bags Due to Sterility Concerns

Walgreens Infusion Services is recalling 95 bags of Vancomycin Injection in NS due to a lack of assurance of sterility. The affected products were distributed in Texas.

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. According to the rubric, FDA Class II recalls with potential for serious injury (such as sterility issues in injectable drugs) are categorized as Severe, especially when no specific hospitalization reports are provided to lower the score to High, but the defect is structural/quality-based rather than minor labeling.

Plain-English summary

Walgreens Infusion Services is recalling 95 Accuflo bags of Vancomycin Injection in NS, compounded by Option Care 148 in San Antonio, Texas. The recall was initiated due to a lack of assurance of sterility. The affected products include various concentrations and volumes, specifically 500 mg/NS 100 mL, 1G/NS 100 mL, 1G/NS 250 mL, 1.5G/NS 250 mL, and 750 mg/NS 100 mL. All lots are within their expiry dates.

The recall is classified as FDA Class II. The products were distributed in Texas. The source text does not specify the exact number of patients affected or report any illnesses or injuries associated with the use of these products.

Consumers and healthcare providers who have these specific products should stop using them and contact their healthcare provider or the recalling firm for further instructions. The recall number is D-0528-2016.

The recalled product

Product
Vancomycin Injection in NS, Accuflo bag, a) 500 mg/NS 100 mL, b)1G/NS 100 mL, c) Vancomycin 1G/NS 250 mL, d) 1.5G/NS 250 mL e) 750 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Manufacturer
Walgreens Infusion Services
Category
Drug — Injectable
Hazard
Affected units
95

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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