Agency classClass IIOur severity:High FDA (Drugs)·D-0051-2022·Announced 2021-11-03

Vitamin B Complex Injectable Solution Recalled for Sterility Concerns

Red Mountain Compounding Pharmacy is recalling Vitamin B Complex Injectable Solution (HP) due to lack of assurance of sterility raised during FDA inspection. Approximately 494 patients across seven states received affected prescriptions.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The product is a prescription injectable medication and the recall involves a critical quality failure—lack of sterility assurance—which poses risk of harm. The source text does not report any actual illnesses or injuries, making this a theoretical risk scenario that qualifies as High severity under the rubric.

Plain-English summary

Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling Vitamin B Complex Injectable Solution (HP), a prescription injectable medication, due to sterility assurance concerns identified during an FDA inspection.

The FDA raised concerns that the product lacks adequate assurance of sterility, a critical quality attribute for injectable medications. All lots within expiry are affected by this recall.

Approximately 494 patients and consumers who received prescriptions are located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. Consumers who have received this product should consult with their healthcare provider or pharmacist regarding their prescription and whether they need medical follow-up.

The recalled product

Product: VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Injectable Compounded Medication
Hazard: lack-of-sterility
contamination-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)

all lots within expiry

Distribution

Distributed in 7 states:

Part of a larger recall action

This product is one of 40 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 40 products in this recall →

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

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