March 2023: Pfizer announced a supply disruption of Pfizer’s Solu-Cortef® (hydrocortisone sodium succinate for injection, USP) 100 mg/2 mL (50 mg/mL) ACT-O[1]VIAL™ Single Dose Vial presentations and provide guidance on how to access product reserved for patient specific emergency needs. Currently, all Solu-Cortef® (hydrocortisone sodium succinate for injection, USP) inventory is available from Pfizer through direct order only, and Pfizer is allocating limited quantities to institutions with a history of product purchases. Pfizer provides guidance to clinicians for utilizing emergency request process for obtaining the medication. The disruption is anticipated until June 2023.

In the meantime, Pfizer recommends the following:

“Under Pfizer’s emergency request process Pfizer will distribute Solu-Cortef® (hydrocortisone sodium succinate for injection, USP) 100 mg/2 mL (50 mg/mL) ACT[1]O-VIAL™ Single Dose Vial, NDC 00009-0011-03, direct to healthcare providers (HCPs) or pharmacies only in situations in which providers or pharmacies are unable to gain access to product through direct order from Pfizer.

  • HCPs or pharmacies can request product under the emergency request process by completing the Emergency Request Form. Completed forms should be emailed to PISupplyContinuity@pfizer.com. Requests will be reviewed and filled in the order they are received and only with the completed documentation. Solu-Cortef Emergency Request Form.pdf (pfizerhospitalus.com).
  • If a pharmacy cannot find Solu-cortef, there is a toll-free number for Pfizer’s Supply Continuity Team between 7 a.m. and 6 p.m. (CT) at 1-844-646-4398 (select option 1 [Customer], then option 3 [Supply Continuity Team]) to arrange for a drop shipment

UPDATED

This letter is a Notification of Emergency Date Extension for Solu-Cortef® (hydrocortisone sodium succinate for injection, USP) 100 mg/2 mL (50 mg/mL) ACT-O-VIAL™ Single Dose Vial. There are 32 lots listed in the table included at the end of the letter from Pfizer that have been extended by five months beyond the labeled 36-month expiry by the FDA. The estimated recover date is December 2023. Refer to https://www.pfizerhospitalus.com/sites/default/files/news_announcements/5-4-23%20Solu-Cortef%20Emergency%20Date%20Extension.pdf

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