The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0257-2020·Announced 2019-11-13

Red Mountain Compounding Recalls Vitamin D3 Injection Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling specific lots of Vitamin D3 10,000 IU/mL oil injection due to a lack of assurance of sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for drug recalls involving potential serious health consequences.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling specific lots of S-VITAMIN D3 10,000 IU/ML OIL MDV INJ. The product is a prescription-only medication available in 5ml and 10ml glass vials. The recall was initiated because of a lack of assurance of sterility.

The affected product was distributed nationwide in the USA. The recall covers 16 specific 5ml and 10ml glass vials identified by the following lot numbers and expiration dates: 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), and S07242019DH@10 (Exp 11/24/19).

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be discontinued and returned to the pharmacy or manufacturer for disposal or credit.

The recalled product

Product
S-VITAMIN D3 10,000 IU/ML OIL MDV INJ, Rx Only, a) 5ml b) 10 ML glass vial. Red Mountain Compounding Rx.
Manufacturer
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category
Drug — Injectable
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 100 recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 100 products in this recall →

Related recalls

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

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Same hazard · sterility

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