The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0537-2016·Announced 2016-01-06

Walgreens Recalls Oxacillin Infusion Bags Due to Sterility Concerns

Walgreens Infusion Services is recalling 14 bags of compounded Oxacillin 12 g/NS 270 mL due to a lack of assurance of sterility. The product was 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 and involves a lack of assurance of sterility in an infusion product, which poses a risk of serious injury or death from infection, meeting the criteria for a Severe rating.

Plain-English summary

Walgreens Infusion Services is recalling 14 bags of Oxacillin 12 g/NS 270 mL-24 hr Accuflo bags. The product is compounded by Option Care 148 in San Antonio, Texas, and is available by prescription only. The recall is being conducted because of a lack of assurance of sterility.

The affected product was distributed in Texas. The recall includes all lots within the expiry date. The FDA has classified this recall as Class II.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Manufacturer
Walgreens Infusion Services
Category
Drug — Infusion Therapy
Hazard
Affected units
14

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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