The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0928-2016·Announced 2016-06-08

Invanz IV Bags Recalled for Lack of Sterility Assurance

Baptist Health Medical Towers Pharmacy is recalling 24 bags of Invanz 1 gram in 100 mL 0.45% NS due to lack of sterility assurance.

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, which corresponds to a Severe severity score per the rubric, particularly given the risk of infection from lack of sterility assurance in an IV product.

Plain-English summary

Baptist Health Medical Towers Pharmacy and Infusion Services in Little Rock, Arkansas, is recalling 24 bags of Invanz 1 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY. The recall is due to a lack of sterility assurance.

The affected product was distributed in Arkansas. The recall includes all product remaining within its expiry date.

Consumers and healthcare providers should stop using the affected product and contact the recalling firm for further instructions.

The recalled product

Product
Invanz 1 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Affected units
24

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 product remaining within expiry.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 38 recalled by Baptist Health Medical Towers Pharmacy and 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 38 products in this recall →

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