Agency classClass IIOur severity:Severe FDA (Drugs)·D-0057-2022·Announced 2021-11-03

Folic Acid 10mg/mL Injectable Recalled Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling folic acid injectable medication because the FDA found the product lacks adequate sterility assurance. The recall affects prescriptions distributed across multiple states.

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: This is an FDA Class II recall. A non-sterile injectable medication poses a serious risk of infection, particularly given that injectable drugs directly enter the bloodstream. Class II recalls with risk of serious adverse health consequences warrant a score of 4, even absent reported illnesses to date.

Plain-English summary

Red Mountain Compounding Pharmacy (operating as First Royal Care Co. LLC) is recalling Folic Acid 10mg/mL multi-dose vial injectable medication (prescription only) due to lack of assurance of sterility. The FDA inspection identified concerns with the compounding facility's sterility assurance processes.

This recall affects 494 patients and consumers who received prescriptions. Distribution includes Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All lots currently within expiration date are included in the recall.

Patients who have received this medication should contact their healthcare provider or pharmacy for guidance. Do not use the product without consulting a healthcare professional first.

The recalled product

Product: FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Injectable / Compounded
Hazard: lack-of-sterility
infection-risk
contamination

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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