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Reporting a Medication Error

Confusing Expiration Information on Some Paxlovid Prescriptions

Published May 19, 2023

Paxlovid (a combination of nirmatrelvir and ritonavir) is an antiviral medicine used to treat patients who are at a high risk of serious illness after testing positive for coronavirus disease 2019 (COVID-19). In December 2021, the US Food and Drug Administration (FDA) approved Paxlovid under an Emergency Use Authorization (EUA). The EUA allows the FDA, in emergency situations, to permit human use of medicines or vaccines that are not yet approved.

Figure 1. A package of Paxlovid indicating the new expiration date with a yellow sticker. The red arrow indicates where the lot number can be found.

The manufacturer of Paxlovid is Pfizer. Under the EUA, Pfizer was told Paxlovid would expire after 12 months from the date the medicine was manufactured. However, in January 2023,the FDA and the US Health and Human Services (HHS) authorized an extension to the expiration date. Therefore, the date that is printed on the carton is incorrect and has caused confusion.

For example, the FDA has received reports from patients concerned about receiving expired medicine. The outer carton and blister cards (that hold the medicine) inside the carton have the original EUA expiration date (e.g., 03/2023) printed on their labels. However, the pharmacy label has the extended expiration date (e.g., 05/2024). There is also confusion when the expiration date on the carton is crossed out and changed.

In one case, a person reported that the original outer carton label expiration date was removed, and a date of 02/2024 was written on the box. However, when the medicine box was opened, the patient noticed an expiration date of 04/2023. Not knowing about the approved expiration date extension, the person thought that expiration date tampering had occurred! Other people reported that they had ingested expired Paxlovid, not knowing the expiration date had been extended.

Here's what you can do: Be aware that different lots of Paxlovid have been approved for use beyond the original expiration date. Therefore, the pharmacy may cross out the original date or place a sticker on the package informing people of the expiration date change (Figure 1). In addition, if the date was changed on the outer package, it may be different than the date on the actual blister cards inside the package. If you are unsure about any former prescription or new prescription expiration dates, you can check the HHS list by using the batch number (LOT) found on the outer carton of Paxlovid.

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