PlainRecalls
FDA Drug Moderate Class II Terminated

S-VITAMIN D3 10,000 IU/ML OIL MDV INJ, Rx Only, a) 5ml b) 10 ML glass vial. Red Mountain Compounding Rx.

Reported: November 13, 2019 Initiated: August 12, 2019 #D-0257-2020

Product Description

S-VITAMIN D3 10,000 IU/ML OIL MDV INJ, Rx Only, a) 5ml b) 10 ML glass vial. Red Mountain Compounding Rx.

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
16x5 and 10 ml glass vials
Distribution
Nationwide in the USA
Location
Mesa, AZ

Frequently Asked Questions

What product was recalled?
S-VITAMIN D3 10,000 IU/ML OIL MDV INJ, Rx Only, a) 5ml b) 10 ML glass vial. Red Mountain Compounding Rx.. Recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy. Units affected: 16x5 and 10 ml glass vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on November 13, 2019. Severity: Moderate. Recall number: D-0257-2020.