The Recall Desk
HighFDA (Drugs)·D-0930-2016·Announced 2016-06-08

Baptist Health Recalls Milrinone IV Bags Due to Sterility Concerns

Baptist Health Medical Towers Pharmacy is recalling Milrinone 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 involves a sterile medical product with a lack of sterility assurance, which poses a risk of harm (infection) even though no injuries have been reported, fitting the High severity criteria for risk-of-harm products.

Plain-English summary

Baptist Health Medical Towers Pharmacy and Infusion Services in Little Rock, Arkansas, is recalling Milrinone 200 mcg/mL IV bags. The affected products are available in 300 mL, 400 mL, 500 mL, and 600 mL volumes in D5W solution. The recall involves 15 bags of the 300 mL, 400 mL, and 500 mL sizes, and 4 bags of the 600 mL size.

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 illnesses or injuries associated with the use of these products. The distribution was limited to Arkansas.

Healthcare providers and patients should stop using the recalled Milrinone IV bags immediately. The source text does not provide specific instructions for disposal or replacement, but standard medical protocols for recalled sterile products should be followed.

The recalled product

Product
Milrinone 200 mcg/mL in a) D5W-300 mL, b) D5W-400 mL, c) D5W-500 mL and d) D5W-600 mL Bags, 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 →