Drug recall: C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy…

Patient Specific Prescriptions in NJ

Colonia Care Pharmacy, Colonia, NJ.

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 2019

362

Share of these events in Class II

68%

Product records in this event

32Median of the firm: 32

Events of the firm on the register

2

• FDA enforcement report D-0003-2020The 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: Patient Specific Prescriptions in NJ

What quantity of product is in FDA event 83427?

The event has 32 product records. The first record gives this quantity: 2 droptainer bottles

How did the recall start?

The FDA record says: Voluntary: Firm initiated

How many drug recalls of 2019 have the same class?

68% of the 362 drug events that started in 2019 are in Class II.