Drug recall: Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose…

Nationwide USA

CARDINAL HEALTHCARE, Dublin, OH.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

Drug events that started in 2022

325

Share of these events in Class II

65%

Product records in this event

42

Events of the firm on the register

1

• FDA enforcement report D-0161-2024The FDA record of the first product of this event.
• FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
• FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Where was the product distributed?

The FDA record gives this distribution: Nationwide USA

What quantity of product is in FDA event 89450?

The event has 42 product records. The first record gives this quantity: 2 cartons

How did the recall start?

The FDA record says: Voluntary: Firm initiated

How many drug recalls of 2022 have the same class?

65% of the 325 drug events that started in 2022 are in Class II.