RecallRadar

FDA Drug recall D-0257-2020

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

On 2019-11-13 the FDA classified a Class II recall of S-VITAMIN D3 10,000 IU/ML OIL MDV INJ, Rx Only, a) 5ml b) 10 ML glass vial by First Royal Care, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0257-2020
ClassificationClass II
Statusterminated
Initiated2019-08-12
Published2019-11-13
Last updated2026-09-13 11:52 UTC
CompanyFirst Royal Care
DistributionUS

Product

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

Reason

Lack of Assurance of Sterility

Identifiers

code_info
Lot #: S04092019DT@16, Exp 8/9/19; S05012019DT@08, Exp 9/1/19; S05152019DT@01, Exp 9/15/19; S06112019DH@18, Exp 10/11/…Lot #: S04092019DT@16, Exp 8/9/19; S05012019DT@08, Exp 9/1/19; S05152019DT@01, Exp 9/15/19; S06112019DH@18, Exp 10/11/19; S06122019DT@06, Exp 10/12/19; S06192019DT@10, Exp 10/19/19; s07092019dt@16, Exp 11/9/19; S07242019DH@10, Exp 11/24/19

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0257-2020%22

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