Recall

FDA Details Manufacturing Conditions That Led to Eye Drop Recall

by Hayden Schmidt

After a series of infections that left several blind, an FDA inspector discovered that the manufacturing facility used to create Global Pharma’s artificial tears failed to follow evidence-based...

FDA Announces Recall of Frozen Fruit from Costco, Aldi, Trader Joe’s

by Veronica Salib

On Friday, March 17, 2023, the FDA announced that Scenic Fruit Company has voluntarily recalled some of its frozen fruit sold at Aldi, Trader Joe’s, and Costco. This announcement was just one day...

Pfizer Recalls Migraine Medication Under Advisement From CPSC

by Veronica Salib

On March 16, 2023, just days after the FDA approved another new nasal migraine medication, Pfizer recalled its Nurtec ODT medication. Under advisement from the United States Consumer Product Safety...

FDA Requires Anaphylaxis Warning for All Allergenic Extracts

by Veronica Salib

On March 3, 2023, the FDA issued a safety communication, announcing that it would require and approve changes to prescribing information labels for all allergenic extracts. The new labels should...

FDA Adds Two Eye Drops to Its Recall List Due to Supply Chain Issues

by Veronica Salib

Last week, the FDA added two more eye drops to its recall list: Apotex Corp Brimonidine Tartrate Ophthalmic Solution (0.15%) and Pharmedica USA LLC Purely Soothing 15% MSM Drops. These recalls follow a...

Reckitt Recalls Plant-Based Infant Formula Due to Health Risk

by Veronica Salib

Reckitt, a consumer goods company, recently issued a recall on two batches of its Enfamil 12.9 oz ProSobee Simply Plant-Based Infant Formula, amounting to more than 140,000 cans, due to potential...

Global Pharma Healthcare Recalls Artificial Tears Due to Contamination

by Veronica Salib

Global Pharma Healthcare has voluntarily recalled multiple batches of artificial tears after patients experienced severe side effects, such as vision loss and mortality. On January 31, 2023, the CDC...

Understanding Pharmaceutical Recalls, Key Players, and Their Roles

by Veronica Salib

Like any industry, recalls in the pharmaceutical industry are complex and expensive. However, as an added concern, pharmaceutical recalls have the potential to alter short and long-term health outcomes. Understanding the recall process for...

How to Improve Regulatory Measures for Dietary Supplements

by Veronica Salib

Across every pharmacy, grocery store, and convenience store in the United States, dietary supplements — in some shape or form — line the shelves. Many patients have the misconception that because these products are sold and...

Valisure Petitions FDA to Recall Dry Shampoos

by Veronica Salib

Last month, Unilever North America voluntarily recalled multiple dry shampoo products, citing the presence of benzene in the propellant as the primary source. Since then, Valisure LLC, an independent...

Unilever Dry Shampoos Recalled Due to Carcinogens

by Veronica Salib

In an announcement published by the FDA on October 21, 2022, Unilever North America — a New Jersey-based cosmetics company — voluntarily recalled multiple dry shampoo aerosol products...

US FDA Accelerated Approval for 48 Non-oncology Drugs

by Veronica Salib

The FDA approval process is multi-faceted and involves several aspects. One of these aspects is accelerated approval, which is meant to approve drugs to treat severe or fatal diseases. According to a...

Lyons Magnus Recalls Products due to Microbial Contamination

by Veronica Salib

Lyons Magnus LLC, a part of the food service industry, recently recalled several products due to potential microbial contamination. In the company statement, Cronobacter sakazakii and Clostridium...

Nephron Pharmaceuticals Recalls 2.1 Million Doses of Medicine, Medical Equipment

by Alivia Kaylor

According to the FDA’s enforcement report, Nephron Sterile Compounding Center, in Columbia, South Carolina, is recalling 2,158,351 medical products including syringes and bags because of a lack...