The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0530-2016·Announced 2016-01-06

Walgreens Recalls Invanz Minibags Due to Sterility Assurance Concerns

Walgreens Infusion Services is recalling 52 Invanz minibags in Texas due to a lack of assurance of sterility. No illnesses have been reported.

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 involving significant injury/property-damage reports or hospitalization are Severe. While no injuries are reported, the lack of sterility assurance in a drug product is a significant hazard that aligns with the Severe classification for Class II recalls with potential for serious harm.

Plain-English summary

Walgreens Infusion Services is recalling 52 minibags of Invanz 1 g/NS 100 mL. The product was compounded by Option Care 148 in San Antonio, Texas, and distributed within Texas. The recall was initiated due to a lack of assurance of sterility.

The affected product is prescription-only. The recall covers all lots within their expiry dates. No specific lot numbers are provided in the source text.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
Invanz 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Hazard
Affected units
52

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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