Drug Safety Alerts

Intralipid 20 % Class I Recall

11/1/17

On November 1, 2017, the United States Food and Drug Administration (FDA) issued a notice regarding a Class I recall of Intralipid^® 20 % NDC # 00338-0519-58 manufactured by Baxter Healthcare. This recall was issued because the product was exposed to subfreezing temperatures during transit which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.

This recall affects lot number 10LE9597 exp. 04/01/19. The affected lot went into distribution on August 11, 2017.

Please note: This recall was originally issued to the retail-level on October 6, 2017. The FDA classified this as a Class I recall on November 1, 2017.

CVS Caremark Response:

Please note: this product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information, health care providers may contact Baxter Healthcare at 1-800-437-5176, Monday through Friday, 7:00 am to 6:00 pm (CT) or visit https://www.baxter.com/. You may also contact the FDA at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.accessdata.fda.gov/.