Red Mountain Compounding Recalls S-Cyanocobalamin Injections Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling specific lots of S-Cyanocobalamin 1,000 mcg/mL injection solution because the product lacks 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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls are typically scored as 4 (Severe), especially when involving potential contamination or sterility issues in injectable drugs, even without reported hospitalizations in the text.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Cyanocobalamin 1,000 mcg/mL MDV Injection Solution. The affected product is packaged in 10 ml and 30 ml glass vials and is available by prescription only. The recall covers specific lots distributed nationwide in the USA.
The recall was initiated due to a lack of assurance of sterility. The source text does not specify the exact cause of the sterility issue or report any illnesses or injuries associated with the product.
Healthcare providers and consumers should stop using the affected lots immediately. The specific lot numbers and expiration dates are listed in the structured product information. Patients who have received these injections should contact their healthcare provider for guidance.
The recalled product
- Product
- S-CYANOCOBALAMIN 1,000 MCG/ML MDV INJ SOLN, packaged in a) 10ml and b) 30 ml glass vial, Rx Only, Red Mountain Compounding Rx.
- Category
- Drug — Injectable Solution
- 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 (11)
- Lot #: a) S05312019DT@03
- Exp 8/31/19
- S06032019DT@05
- Exp 9/3/19 S06122019DT@07
- Exp 9/12/19
- b) S05312019DT@07
- S06122019DT@07
- S06252019DH@11
- Exp 9/25/19
- S07172019DT@01
- Exp 10/25/19
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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