PlainRecalls
FDA Drug Moderate Class II Terminated

HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx

Reported: November 3, 2021 Initiated: August 13, 2021 #D-0039-2022

Product Description

HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx

Reason for Recall

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Details

Units Affected
N/A
Distribution
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
Location
Mesa, AZ

Frequently Asked Questions

What product was recalled?
HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx. Recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy. Units affected: N/A.
Why was this product recalled?
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Which agency issued this recall?
This recall was issued by the FDA Drug on November 3, 2021. Severity: Moderate. Recall number: D-0039-2022.