Agency classClass IIOur severity:Severe FDA (Drugs)·D-0255-2020·Announced 2019-11-13

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.

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 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
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Injectable
Hazard: sterility-failure
infection-risk

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.

See all 100 products in this recall →

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

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