The Recall Desk
HighFDA (Drugs)·D-0926-2016·Announced 2016-06-08

Baptist Health Recalls Ertapenem IV Bags Due to Sterility Concerns

Baptist Health Medical Towers Pharmacy is recalling ertapenem IV bags in Arkansas due to a lack of sterility assurance.

What this means for you

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 (IV medication) where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

Baptist Health Medical Towers Pharmacy and Infusion Services in Little Rock, Arkansas, is recalling ertapenem 1 gram Add-Vantage in 50 mL and 100 mL 0.45% NS bags. The recall involves 16 bags of the 50 mL size and 18 bags of the 100 mL size. The product is intended for intravenous use only.

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

The affected products were distributed in Arkansas. The recall covers all product remaining within its expiry date. Healthcare providers and patients who have received or used these specific bags should contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Ertapenem 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR

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 →