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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
- 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.
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