Drug recall: ACETYLCYSTEINE OPTH 10% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS…

AL, LA, MS, and TN

Pharmacy Plus, Inc. dba Vital Care Compounder, Hattiesburg, MS.

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

32Median of the firm: 21

Events of the firm on the register

3

Pharmacy Plus, Inc. dba Vital Care Compounder: all 3 events

• FDA enforcement report D-0026-2023The 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.

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Where was the product distributed?

The FDA record gives this distribution: AL, LA, MS, and TN

What quantity of product is in FDA event 90982?

The event has 32 product records. The first record gives this quantity: 1 droptainer

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.