Red Mountain Compounding Recalls S-Vit B Complex Injection for Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Vit B Complex Injection vials due to a lack of assurance of sterility. The product was distributed nationwide in the USA.
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 source text identifies the agency classification as Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant injury or property damage reports, or in this case, a critical sterility failure in an injectable drug which carries inherent risk of serious infection.
Plain-English summary
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy, is recalling S-Vit B Complex (1/3/5/6/12A) MDV Injection, 30 ml glass vials. The recall is being conducted due to a lack of assurance of sterility. The affected product is identified by Lot # S07232019DH@08 with an expiration date of 10/23/19.
The product was distributed nationwide in the USA. The quantity involved in the recall is 2x30 ml glass vials. No specific number of affected units or reported illnesses is provided in the source text.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- S-VIT B COMPLEX (1/3/5/6/12A) MDV INJ 100/2/2/100/1MG/ML, 30 ML glass vial. Red Mountain Compounding Rx
- Category
- Drug — Injectable
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 (1)
- Lot #: S07232019DH@08 Exp 10/23/19
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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