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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Red Mountain Compounding Pharmacy Sterile Injectable and Ophthalmic Drugs Recalled

Agency Publication Date: October 26, 2021
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Summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling various sterile injectable and ophthalmic (eye) medications because of concerns about the lack of sterility assurance. Approximately 494 patients and consumers in several states received these prescriptions. The recall includes products like Testosterone, Vitamin B Complex, and various eye solutions compounded at the Mesa, Arizona facility.

Risk

Injectable or eye medications that are not sterile can cause serious, life-threatening infections. While no injuries or illnesses have been reported to date, any product intended for injection or use in the eyes must be sterile to be safe for use.

What You Should Do

  1. This recall involves various sterile injectable and eye medications sold under the brand name Red Mountain Compounding Rx, including Calcium Chloride, Magnesium Chloride, Testosterone Cypionate, Vitamin B-Complex, and Methylcobalamin. All lots within their expiration dates are included. See the Affected Products section below for the full list of affected codes.
  2. If you have health concerns regarding a product you have used, contact your healthcare provider or pharmacist immediately.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report a problem.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Calcium Chloride, 100 mg/mL MDV INJby Red Mountain Compounding Rx
Variants: 100 mg/mL, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0028-2022

Product: Magnesium Chloride, 200 mg/mL MDV INJby Red Mountain Compounding Rx
Variants: 200 mg/mL, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0029-2022

Product: LEVOCARNITINE 100MG/ML MDV SOLNby Red Mountain Compounding Rx
Variants: 100 mg/mL, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0030-2022

Product: ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLNby Red Mountain Compounding Rx
Variants: 500 mg/mL, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0031-2022

Product: ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF)by Red Mountain Compounding Rx
Variants: 500 mg/mL, Preservative-Free (PF)
Lot Numbers:
all lots within expiry

Recall #: D-0032-2022

Product: ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLNby Red Mountain Compounding Rx
Variants: 1.25/1.25%, Ophthalmic Solution
Lot Numbers:
all lots within expiry

Recall #: D-0033-2022

Product: CYCLOSPORIN 0.2% OIL OPTH SUSPby Red Mountain Compounding Rx
Variants: 0.2%, Ophthalmic Suspension
Lot Numbers:
all lots within expiry

Recall #: D-0034-2022

Product: CYCLOSPORINE 2% MCT OIL SUSPby Red Mountain Compounding Rx
Variants: 2%, MCT Oil Suspension
Lot Numbers:
all lots within expiry

Recall #: D-0035-2022

Product: DEXPANTHENOL 250MG/ML INJ SOLNby Red Mountain Compounding Rx
Variants: 250 mg/mL, Injectable Solution
Lot Numbers:
all lots within expiry

Recall #: D-0036-2022

Product: ESTRADIOL VALERATE 5MG/ML MDV INJby Red Mountain Compounding Rx
Variants: 5 mg/mL, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0037-2022

Product: GLUTATHIONE 200MG/ML MDVby Red Mountain Compounding Rx
Variants: 200 mg/mL, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0038-2022

Product: HYDROXYPROG CAPROATE 250MG/ML OIL INJby Red Mountain Compounding Rx
Variants: 250 mg/mL, Oil Injection
Lot Numbers:
all lots within expiry

Recall #: D-0039-2022

Product: LEVOCARNITINE 100MG/ML MDV SOLNby Red Mountain Compounding Rx
Variants: 100 mg/mL, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0040-2022

Product: PYRIDOXINE HCL (B6) 100MG/ML MDVby Red Mountain Compounding Rx
Variants: 100 mg/mL, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0041-2022

Product: TEST CYP 100MG/ML IN ETHYL OLEATE OILby Red Mountain Compounding Rx
Variants: 100 mg/mL, Ethyl Oleate Oil
Lot Numbers:
all lots within expiry

Recall #: D-0042-2022

Product: TEST CYP 200MG/ML IN SESAME OIL MDVby Red Mountain Compounding Rx
Variants: 200 mg/mL, Sesame Oil, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0043-2022

Product: TEST CYP 200MG/ML MDV ETHYL OLEATEby Red Mountain Compounding Rx
Variants: 200 mg/mL, Ethyl Oleate, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0044-2022

Product: TEST CYP 25MG/ML IN ETHYL OLEATE MDVby Red Mountain Compounding Rx
Variants: 25 mg/mL, Ethyl Oleate, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0045-2022

Product: TEST CYP 50MG/ML IN ETHYL OLEATE OILby Red Mountain Compounding Rx
Variants: 50 mg/mL, Ethyl Oleate Oil
Lot Numbers:
all lots within expiry

Recall #: D-0046-2022

Product: TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATEby Red Mountain Compounding Rx
Variants: 160/40 mg/mL, Ethyl Oleate, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0047-2022

Product: TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OILby Red Mountain Compounding Rx
Variants: 125 mg/mL (80/10/10), Sesame Oil
Lot Numbers:
all lots within expiry

Recall #: D-0048-2022

Product: TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OILby Red Mountain Compounding Rx
Variants: 125 mg/mL (80/10/10), Sesame Oil
Lot Numbers:
all lots within expiry

Recall #: D-0049-2022

Product: TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OILby Red Mountain Compounding Rx
Variants: 250 mg/mL, Sesame Oil, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0050-2022

Product: VIT B COMPLEX INJ SOLN (HP)by Red Mountain Compounding Rx
Variants: High Potency (HP), Injectable Solution
Lot Numbers:
all lots within expiry

Recall #: D-0051-2022

Product: VIT B COMPLEX INJ SOLN (HP)by Red Mountain Compounding Rx
Variants: High Potency (HP), Injectable Solution
Lot Numbers:
all lots within expiry

Recall #: D-0052-2022

Product: ACETYLCYSTEINE 10% OPTH SOLNby Red Mountain Compounding Rx
Variants: 10%, Ophthalmic Solution
Lot Numbers:
all lots within expiry

Recall #: D-0053-2022

Product: ACETYLCYSTEINE 2% OPTH SOLNby Red Mountain Compounding Rx
Variants: 2%, Ophthalmic Solution
Lot Numbers:
all lots within expiry

Recall #: D-0054-2022

Product: BENZALKONIUM CHLORIDE 0.013% SOLUTIONby Red Mountain Compounding Rx
Variants: 0.013%
Lot Numbers:
all lots within expiry

Recall #: D-0055-2022

Product: CALCIUM GLUCONATE 10% INJ (PF)by Red Mountain Compounding Rx
Variants: 10%, Preservative-Free (PF)
Lot Numbers:
all lots within expiry

Recall #: D-0056-2022

Product: FOLIC ACID 10MG/ML MDV INJby Red Mountain Compounding Rx
Variants: 10 mg/mL, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0057-2022

Product: METHYLCOBALAMIN 10,000MCG/ML MDV INJby Red Mountain Compounding Rx
Variants: 10,000 mcg/mL, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0058-2022

Product: METHYLCOBALAMIN 1000MCG/ML MDV INJby Red Mountain Compounding Rx
Variants: 1000 mcg/mL, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0059-2022

Product: METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLNby Red Mountain Compounding Rx
Variants: 12.5 mg/mL, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0060-2022

Product: METHYLCOBALAMIN 5000MCG/ML MDV INJby Red Mountain Compounding Rx
Variants: 5000 mcg/mL, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0061-2022

Product: MIC 25/50/50MG/ML MDVby Red Mountain Compounding Rx
Variants: 25/50/50 mg/mL, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0062-2022

Product: MIC/B12A 25/50/50MG/ML 1MG/ML MDVby Red Mountain Compounding Rx
Variants: 25/50/50 mg/mL + 1 mg/mL, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0063-2022

Product: MIC/B12A/B6 15/50/100 5MG/50MG/ML MDVby Red Mountain Compounding Rx
Variants: 15/50/100 5mg/50mg/mL, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0064-2022

Product: MIT/B12 25/50/50MG/ML 1MG/ML MDVby Red Mountain Compounding Rx
Variants: 25/50/50 mg/mL + 1 mg/mL, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0065-2022

Product: PROGESTERONE 100MG/ML MDV OIL INJECTIONby Red Mountain Compounding Rx
Variants: 100 mg/mL, Oil Injection, Multi-Dose Vial (MDV)
Lot Numbers:
all lots within expiry

Recall #: D-0066-2022

Product: SODIUM SELINITE 200MCG/ML FOR INJby Red Mountain Compounding Rx
Variants: 200 mcg/mL
Lot Numbers:
all lots within expiry

Recall #: D-0067-2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88693
Status: Resolved
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Sold By: Red Mountain Compounding Pharmacy
Manufactured In: United States
Distributed To: Arizona, California, Florida, Minnesota, Montana, Texas, Utah

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.