HCR 576 Module 5 Recent Drug Recall Paper Example

Course	HCR 576 Drug Discovery, Development and Regulations
Module	Module 5
Paper type	Recall case paper
Length	About 669 words, 5 pages
Format	APA 7 student paper
School	Arizona State University
Program	MS in Regulatory Science
Updated	October 2026

Free sample paper for HCR 576 Module 5

Contaminated Eye Drops and the Recall Process: The 2023 Artificial Tears Outbreak From Detection to Termination

Student Name

MS in Regulatory Science, Arizona State University

HCR 576: Drug Discovery, Development and Regulations

Instructor Name

Month Day, Year

What this page is doingThe title names the product problem and frames the paper as a walk through the recall process.

Contaminated Eye Drops and the Recall Process: The 2023 Artificial Tears Outbreak From Detection to Termination

Introduction

A recall removes or corrects a marketed product that violates FDA requirements. Most drug recalls are voluntary actions by the company, monitored and classified by the FDA. The 2023 artificial tears recall shows the process under pressure: an over-the-counter product, made overseas, caused severe infections before anyone knew it was contaminated.

Detection

In 2022, clinicians and public health laboratories identified infections with a strain of carbapenem-resistant Pseudomonas aeruginosa carrying the VIM and GES resistance genes, a combination never before reported in the United States. On February 1, 2023, CDC issued a health advisory reporting cases in 12 states and identifying EzriCare Artificial Tears, a preservative-free product, as the most common exposure (Centers for Disease Control and Prevention [CDC], 2023). By May, 81 patients in 18 states had been identified; 14 lost vision, 4 had an eye surgically removed and 4 died.

What this page is doingThe surveillance step comes first because a recall can only begin once someone connects illness to a product.

The Recall

The day after CDC's advisory, Global Pharma Healthcare voluntarily recalled all lots of EzriCare Artificial Tears and Delsam Pharma's Artificial Tears, and later added Delsam's Artificial Eye Ointment. FDA recommended that consumers and clinicians stop using the products. FDA guidance describes the steps that follow any recall: the firm develops a recall strategy that sets the depth of recall (wholesale, retail or consumer level), the need for public warning and the effectiveness checks it will perform, and it notifies its consignees, the distributors and retailers it shipped to, telling them to stop distribution and return or destroy product (U.S. Food and Drug Administration [FDA], 2020).

Classification

FDA classifies recalls by hazard. The regulation sorts recalls by danger: Class I when use could reasonably be expected to cause serious injury or death, Class II when harm would be temporary or reversible or serious harm is unlikely and Class III when no harm is expected (21 C.F.R. § 7.3). Given blindness and deaths, the eye drops recall falls in Class I, which calls for recall to the consumer level and a public warning.

Recall step	What happened in this case
Detection	CDC surveillance linked an unusual resistant strain to one product
Firm action	Voluntary recall of all lots, extended to related products
FDA role	Public recommendation to stop use; recall monitoring; import alert and inspection follow-up
Depth	Consumer level, including online sales
Public notice	Firm press release, FDA and CDC communications, clinician outreach
Effectiveness checks	Verifying that consignees received notice and removed product
Termination	When FDA judges that all reasonable efforts to remove product are complete

Inspection Findings and Follow-Up

After the recall, FDA inspected the manufacturing plant in Chennai and reported problems with sterility assurance, a serious concern for a preservative-free product applied to the eye. The agency also placed the firm's products on import alert, which allows them to be refused entry. An ophthalmology editorial praised the speed of the public health detective work but warned that oversight of imported over-the-counter products remains weak (Kuo, 2023).

Temporary Versus Permanent Removal

The syllabus asks about removal from the market temporarily or permanently. A recall of specific lots for a correctable defect can be temporary, with the product returning once the problem is fixed and verified. Here the removal was effectively permanent for these products, because the contamination reflected manufacturing failures rather than a single bad batch, and the firm's products remained subject to import restrictions.

Gaps Exposed

Three gaps stand out. Over-the-counter eye drops can be marketed under monograph without premarket review, so FDA may not inspect an overseas plant before its products reach U.S. shelves. Preservative-free multidose products depend entirely on manufacturing sterility. And online marketplaces complicate consumer-level recall because sellers and buyers are hard to reach.

Conclusion

The artificial tears recall shows each step of the recall process: detection, voluntary action, classification, notification, effectiveness checks and follow-up inspection. It also shows that a recall responds to harm already done. The stronger protections are upstream, in inspections and manufacturing controls that prevent contaminated products from reaching patients at all.

References

Centers for Disease Control and Prevention. (2023, February 1). Outbreak of extensively drug-resistant Pseudomonas aeruginosa associated with artificial tears [Health Alert Network Health Advisory]. https://stacks.cdc.gov/view/cdc/124175

Definitions, 21 C.F.R. § 7.3 (2025).

Kuo, I. C. (2023). Extensively multi-drug-resistant Pseudomonas aeruginosa in artificial tears: Public health sleuthing success but challenges ahead. American Journal of Ophthalmology, 253, xii-xiv. https://doi.org/10.1016/j.ajo.2023.06.011

U.S. Food and Drug Administration. (2020). Product recalls, including removals and corrections [Guidance for industry]. https://www.fda.gov/media/129259/download

What the HCR 576 Module 5 instructions ask for

Week 5 of HCR 576 covers quality in manufacturing, current good manufacturing practices, facility inspections and FDA's bioresearch monitoring program, and Paper 2 applies that material to a recall. The syllabus asks you to look at a recent recall and review the FDA process required, including notification to remove a product from the market temporarily or permanently. The week's readings include FDA's guidance for industry on product recalls, which sets out recall strategy, depth, public warnings, effectiveness checks and termination, so it is the natural framework for organizing the paper. Choose a recall with good public documentation from FDA, CDC or the company, recent enough to count as current, and follow it through each step of the process. Its weight is part of the 22.5% that the three papers carry together.

How this HCR 576 Module 5 example is built

The sample opens by defining a recall and explaining why the chosen case is useful. A detection section describes how surveillance linked an unusual resistant strain to the product, with dates and case counts. The recall section describes the firm's voluntary action and the steps FDA guidance requires, and the classification section cites the regulation and assigns the class. A table maps each recall step to what happened in the case. Inspection follow-up and import action come next, then a section answering the syllabus's question about temporary versus permanent removal, a section on gaps the case exposed and a conclusion arguing that prevention matters more than recall.

Where the marks sit in the HCR 576 Module 5 rubric

The recall paper is scored as one of HCR 576's three papers. Credit goes to a recent, well-documented recall, an accurate account of the FDA recall process from strategy and classification to notification, effectiveness checks and termination, correct recall class definitions, discussion of temporary versus permanent removal as the prompt asks and analysis of what the case reveals about manufacturing quality or oversight. Points are lost when the paper retells news coverage without the process, when recall classes are confused, when the difference between a recall and a withdrawal is blurred and when the manufacturing quality angle of the week is ignored. Readers value cases where the writer connects the recall to its root cause, since the course places recalls inside the study of manufacturing quality.

HCR 576 Module 5 help with common mistakes

Choose a recall with an FDA or CDC record you can cite. Use FDA's recall guidance as your outline: strategy, depth, public warning, effectiveness checks, termination. Look up the recall class and explain why it fits. Address whether the removal was temporary or permanent. Connect the recall to its manufacturing or quality cause. Avoid relying only on news articles. If you are choosing between recalls, the desk can suggest ones with complete public records. Keep a timeline of the recall's key dates, because sequence matters in a recall paper. Finish by naming one prevention step, upstream of the recall, that would have stopped the harm.

Write yours, or have the desk draft it

This paper is an original model document written by our desk, not a submitted student paper and not an official Arizona State University document. Read it for the moves, then write your own to the instructions in your classroom. If you want one built to your exact prompt and rubric, the first custom sample is free and arrives in 24 to 48 hours.

More HCR 576 and MS in Regulatory Science sample papers

HCR 576 Module 5 questions, answered

Where can I find a free HCR 576 Module 5 sample paper?

The complete drug recalls paper, on the 2023 contaminated artificial tears recall, is on this page.

What are the steps in an FDA drug recall?

The firm sets a recall strategy and notifies consignees, FDA classifies the recall, public warnings go out as needed, effectiveness is checked and FDA terminates the recall.

What makes a recall Class I?

The product could reasonably be expected to seriously injure or kill someone who uses it.

Are most drug recalls voluntary?

Yes. Most are initiated by the firm, often after FDA contact, and FDA monitors and classifies them.

Why were the EzriCare artificial tears recalled?

They were linked to an outbreak of an extensively drug-resistant Pseudomonas aeruginosa strain that caused vision loss and deaths.

HCR 576 Module 5 Paper: A Recent Drug Recall and the FDA Process Example