Agency classClass IIOur severity:Severe FDA (Drugs)·D-0789-2017·Announced 2017-05-24

Baxter Recalls Milrinone Lactate Injection Due to Sterility Concerns

Baxter Healthcare is recalling Milrinone Lactate in Dextrose Injection because customer complaints reported leaks, creating a lack of assurance of sterility.

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. Per the rubric, FDA Class II recalls with potential for significant injury (such as sterility failure in an IV drug) are rated as Severe (4), as they are not Class I but involve serious health risks.

Plain-English summary

Baxter Healthcare Corporation is recalling 90,450 bags of Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bags. The recall was initiated due to customer complaints regarding the presence of leaks in the product, which resulted in a lack of assurance of sterility.

The affected product is a prescription-only intravenous medication manufactured by Baxter Healthcare Corporation in Deerfield, IL. The specific lots involved are P342485 (Expiration 11/30/17) and P344408 (Expiration 12/31/17). The product was distributed in the United States and foreign countries, including the United Arab Emirates, Colombia, and Canada.

Healthcare providers and patients should stop using the affected lots and contact Baxter Healthcare Corporation for further instructions or to arrange for a return or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: MILRINONE LACTATE IN DEXTROSE (MILRINONE LACTATE)
Brand: MILRINONE LACTATE IN DEXTROSE
Manufacturer: Baxter Healthcare Corporation
Category: Drug — Intravenous Injection
Hazard: sterility-failure
contamination
Affected units: 90,450

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 (4)

Lot #: P342485
Exp 11/30/17
P344408
Exp 12/31/17

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Baxter Healthcare Corporation 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 2 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · sterility failure