The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0917-2016·Announced 2016-06-08

Baptist Health Recalls Ceftriaxone IV Bags Due to Sterility Concerns

Baptist Health Medical Towers Pharmacy is recalling 16 bags of Ceftriaxone 2 gram IV solution in Arkansas due to a 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (lack of sterility assurance) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Baptist Health Medical Towers Pharmacy and Infusion Services is recalling 16 bags of Ceftriaxone 2 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY. The recall was initiated because of a lack of sterility assurance for the product.

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 recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Ceftriaxone 2 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Manufacturer
Baptist Health Medical Towers Pharmacy and Infusion Services
Category
Drug — IV Solution
Hazard
Affected units
16

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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