Agency classClass IIOur severity:Severe FDA (Drugs)·D-1500-2016·Announced 2016-09-21

Hospira Recalls Dobutamine Injection Vials Due to Discoloration and Particulates

Hospira Inc. is recalling 24,000 vials of Dobutamine Injection due to reports of product discoloration and particulates. The affected lot was distributed nationwide and to Puerto Rico and the Bahamas.

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 temporary or medically reversible adverse health consequences, or where proper labeling is required, are typically scored as Severe (4), especially given the presence of particulates in an IV product.

Plain-English summary

Hospira Inc. is recalling 24,000 vials of DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only. The recall is being conducted because the firm received complaints regarding product discoloration and particulates.

The affected product is identified by Lot # 52175DD with an expiration date of 01 Oct 2016. The NDC number is 0409-2025-20. According to the recall notice, 23,700 units were distributed to the US and Puerto Rico, and 300 units were distributed to the Bahamas. Additionally, 30 units were returned by a customer and destroyed internally.

This recall is classified as FDA Class II. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product is found, it should be quarantined and not used. The firm is responsible for managing the recall and handling any returns.

The recalled product

Product: DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20
Manufacturer: Hospira Inc.
Category: Drug — Injectable
Hazard: contamination
particulates
Affected units: 24,000

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 (2)

Lot #: 52175DD
Exp 01 Oct 2016

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Hospira Inc.

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