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”.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

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.


Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Leadership Development Committee for Suboxone Dental Injury Lawyers Established in Federal MDL
Leadership Development Committee for Suboxone Dental Injury Lawyers Established in Federal MDL (Posted 2 days ago)

The U.S. District Judge presiding over all Suboxone lawsuits has created a mentorship program to use the litigation to provide some attorneys an opportunity to gain experience in handling complex federal multidistrict litigations.

Gilead Settlement Resolves 2,625 HIV Drug Lawsuits Pending in Federal Courts for $40M
Gilead Settlement Resolves 2,625 HIV Drug Lawsuits Pending in Federal Courts for $40M (Posted 4 days ago)

Gilead says it will pay $40 million to resolve HIV drug lawsuits over Truvada, Atripla, Viread, Stribild and Complera pending in the federal court system, involving claims that the the company sat on safer formulations of the drugs for years to increase profits.