Red Mountain Compounding Pharmacy Recalls S-MICB12C/Cartinine Injection Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-MICB12C/Cartinine 25/50/50/1/50MG/ML MDV INJ vials 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. According to the rubric, FDA Class II recalls with potential for serious injury (such as sterility issues in injectable drugs) are categorized as Severe.
Plain-English summary
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy, is recalling S-MICB12C/Cartinine 25/50/50/1/50MG/ML MDV INJ, Rx Only, 30ml vials. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product consists of 2x30ml glass vials. The specific lot numbers involved are S07092019DT@19 (Exp 08/09/2019) and S07292019DH@09 (Exp 08/29/2019). The product was distributed nationwide in the USA.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- S-MICB12C/Cartinine 25/50/50/1/50MG/ML MDV INJ, Rx Only, 30ml, Red Mountain Compounding Rx.
- Category
- Drug — Compounded 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 (4)
- Lot #: S07092019DT@19
- Exp 08/09/2019
- S07292019DH@09
- Exp 08/29/2019
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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