ISMP Warns of Anesthesia Labeled For Animal Use Distributed in Cases Intended for Humans

Isoflurane labeled for animal use is only approved for use on horses and dogs, the ISMP warns

Bottles of the anesthesia drug Isoflurane labeled “for animal use only” may have been shipped to healthcare institutions in cases that were supposed to have versions of the drug for human use, according to a new alert issued by a prominent drug safety group.

The Institute for Safe Medication Practices (ISMP) issued a Isoflurane mislabeling warning on January 9, indicating the anesthetic was packaged and shipped to healthcare facilities labeled as “for animal use only,” even though the facilities ordered Isoflurane for human use. The packaging error resulted in several cases of the wrong type of Isoflurane being shipped to human medical facilities.

Isoflurane is a general anesthetic that is administered via inhalation. It is often used to start or maintain anesthesia during surgery.

The ISMP received reports from multiple healthcare facilities about the isoflurane problem. The facilities recently received orders of isoflurane in cardboard cases labeled “Isoflurane USP 100 mL” by Primal Critical Care which actually contained bottles of Isoflurane by Covetrus labeled “for animal use only.”

The products were distributed by at least two different wholesalers. Multiple organizations reported the same problem and lot number. It is unclear if other lots are also impacted by the Isoflurane mix-up.

The ISMP contacted the manufacturer Primal Critical Care, who has indicated they are aware of the issue and are investigating the problem. The ISMP also notified the U.S. Food and Drug Administration (FDA) in case adverse events may have occurred.

Only Approved for Horses and Dogs

Piramal Critical Care said the product labeled “for animal use only” is only approved for use in horses and dogs.

According to Piramal Critical Care, both products are pure Isoflurane, without any chemical stabilizers. They are made under the same sterile conditions.

There is no significant difference in chemical composition between the products labeled for human and animal use. Yet, there are no clinical studies completed using the product on humans.

Despite the two products having the same composition, a medical facility may be surprised to receive Isoflurane intended for humans, labeled as “for animal use only”.

Facilities receiving the product should inspect the supply to confirm whether it is the approved for human use Isoflurane product or the “for animal use only” Isoflurane product, according to ISMP recommendations.

Facilities should inspect their supply of Isoflurane to confirm the facility has the correct product approved for human use, the ISMP instructed, indicating facilities should not use Isoflurane labeled “for animal use only.”

Facilities should quarantine any inappropriate product and notify the manufacturer, the ISMP, and the FDA of the issue, according to the warning. Any side effects should be reported to the FDA’s MedWatch Adverse Event Reporting Program.