Decade-plus review of drug recall trends from 2011 to 2023

Earlier this year, we took a look at the most common causes of drug-related recalls in 2022 and the first quarter of 2023. Now, we are expanding our lens to examine drug-related FDA recalls from 2011 to 2023.

Understanding the recall landscape

In recent decades, prominent incidents like the Tylenol poisonings in 1982 have underscored the need for attentive tracking, swift reaction and careful mitigation measures when facing possible hazards to health. To get a sense of the current landscape of pharmaceutical recalls, we analyzed an FDA dataset spanning from 2011 to 2023. The data, which includes an array of drugs and recall reasons, found that lack of assurance of sterility continues to be far and away the most common reason for pharmaceutical recalls.

Sterility issues continue to clearly be the most common reason for FDA drug recalls. Data source: FDA

While FDA recalls of drugs have fluctuated widely…

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  • August 3, 2023
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Vick’s Nyquil FDA compliance issues explained

[Dextromethorphan is an active ingredient in NyQuil. Image from raimund14/Adobe Stock]

Procter & Gamble (NYSE:PG) recently received a warning letter from FDA for failing to meet the agency’s requirements in the drug listing. The warning related to Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion (National Drug Code (NDC): 58933-541), a powdered medicine intended to be dissolved in hot water before use.

The FDA’s drug listing process requires submitting information related to a drug product, including its name, active ingredients, dosage form, strength and labeling information. The agency asks that the information be submitted to its electronic Drug Registration and Listing System (eDRLS), an online application.

In its warning letter to Procter & Gamble, FDA noted that it sent a letter dated October 31, 2022 to the manufacturer with a list of deficiencies related to a type of Vicks Ny…

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  • March 21, 2023
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