The FDA announced extended use dates for 72 lots of epinephrine autoinjectors. All of the 72 lots can be used for 2 months past the labeled expiration date, according to stability data supplied by the company and reviewed by the Agency. FDA noted in its announcement (here) that it does not expect or require the product to be relabeled with the revised expiration date, but does expect that “ if replacement product becomes available during the extension period, then the agency expects the lots in these tables will be replaced and properly disposed of as soon as possible.”
The lot numbers for all 73 lots are published in the notice referenced above. The question is how will patients and care givers know that that the product can be safely used after the labeled expiration date? FDA also noted, that as additional data becomes available, the list of lots may expand until the shortage is relieved.
