Agency classClass IIOur severity:High FDA (Drugs)·D-0041-2022·Announced 2021-11-03

Pyridoxine HCL Injection Recalled for Lack of Sterility Assurance

Red Mountain Compounding Pharmacy is recalling pyridoxine HCL (vitamin B6) injectable solution due to lack of assured sterility. Approximately 494 patients in multiple 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: This is an FDA Class II recall involving a parenteral (injectable) drug product with lack of sterility assurance, which is a high-risk contamination hazard. Although no illnesses or injuries are reported in the source text, the potential for serious harm from non-sterile injectable products justifies a High severity rating per the rubric criterion for risk-of-harm products where the hazard is significant.

Plain-English summary

Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling pyridoxine HCL 100 mg/mL multi-dose vials due to lack of assurance of sterility. An FDA inspection identified sterility assurance concerns with the product.

The recalled product was distributed to approximately 494 patients who received prescriptions. Distribution included patients located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All lots of the product within expiry are affected by this recall.

Consumers who received this product should contact their healthcare provider immediately for guidance. Healthcare providers should not administer the recalled product and should discuss alternative treatment options with patients.

The recalled product

Product: PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Injectable / Compounded Pharmaceutical
Hazard: lack-of-sterility
contamination-risk
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 (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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