The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0548-2016·Announced 2016-01-06

Teflaro Infusion Minibags Recalled for Lack of Sterility Assurance

Walgreens Infusion Services is recalling Teflaro 600 mg infusion minibags 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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving significant risks such as sterility issues in infusion products, even without explicit hospitalization reports in the provided text.

Plain-English summary

Walgreens Infusion Services is recalling Teflaro 600 mg in 100 mL NS Minibag Plus, Rx Only, compounded by Option Care 148 in San Antonio, Texas. The recall involves 63 minibags, all of which are within their expiry dates.

The recall was initiated due to a lack of assurance of sterility. The source text does not specify the exact cause of the sterility concern or report any specific illnesses or injuries associated with the use of these products.

The affected products were distributed in Texas. Consumers and healthcare providers who have these specific minibags should stop using them and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Teflaro 600 mg in 100 mL NS Minibag Plus,Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Manufacturer
Walgreens Infusion Services
Category
Drug — Infusion
Hazard
Affected units
63

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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