5/6 March 2024
On 31 January 2023, the U.S. Food and Drug Administration (FDA) has published two Warning Letters to manufactures of hand sanitizer drug products. In both cases, acetaldehyde and acetal impurities at unacceptable levels were found in several lots. The agency is concerned, because acetaldehyde is considered to be genotoxic, and potentially carcinogenic.
The first Warning Letter, dated 27 December 2022, was sent to a company in Pearl River, New York, which is registered as a manufacturer of over-the-counter (OTC) drug products. The FDA conducted testing of different consumer hand sanitizer drug products. In total, four batches were analyzed in an FDA laboratory. In all cases, acetaldehyde and acetal impurities at unacceptable levels were found.
The FDA writes that "acetaldehyde and acetal are known impurities of alcohol, as delineated in the United States Pharmacopeia (USP). The USP monograph for alcohol limits acetaldehyde and acetal to not more than (NMT) 10µL/L, 10 ppm (expressed as acetaldehyde)." It goes on stating that the test results "are unacceptable because these results are higher than the levels expected if the alcohol contained in [the] products complied with compendial standards and if [the company] had conducted finished product testing with a specification for acetaldehyde and acetal."
During FDA's correspondence with the company, it turned out that the company does not have any reserve samples for distributed batches. Therefore, the quality of other lots distributed could not be verified subsequently by the company itself.
The firm plans not to continue manufacturing hand sanitizer drug products. However, this does not relieve the firm’s obligation to comply with CGMP.
The second Warning Letter, dated 18 January 2023, concerns a manufacturer from Irving, Texas. The case is quite similar. Again, samples were collected by the FDA. In all three lots, FDA laboratory testing found acetaldehyde and acetal impurities at unacceptable levels.
In the following, the FDA required the company to perform impurity testing of reserve samples to determine the quality of all lots of the hand sanitizer drug products within expiry. These tests were performed by the company and the test results confirmed that other batches were affected, too.
The company has already initiated a voluntary nationwide recall of the hand sanitizer batches. Nevertheless, the FDA expects the company to take appropriate action and to provide a written response to the Warning Letter.
The two Warning Letters mentioned above are accessible on the FDA's homepage:
There has been a accumulation of FDA Warning Letters to manufactures of hand sanitizer products in the recent past.