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High RiskFDAfda-D-0257-2020STERILITY ISSUE

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

Category
Units Affected
16
Recall Date
August 12, 2019
Issuing Agency
Hazard
Sterility Issue

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-0257-2020.

Lack of Assurance of Sterility

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-0257-2020.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-0257-2020.

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA

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📣 Report a food, supplement, or cosmetic problem to the FDA

If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.

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First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy Recall FAQ

First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy is the subject of a supplements safety report: S-VITAMIN D3 10,000 IU/ML OIL MDV INJ, Rx Only, a) 5ml b) 10 ML glass vial. Red Mountain Compounding Rx.. The notice was published on August 12, 2019 by the U.S. Food and Drug Administration (FDA). Approximately 16 units are potentially affected.