Medications & Supplements/Prescription Drugs

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy: Sterile Compounded Injectable and Ophthalmic Medications Recalled

Agency Publication Date: November 13, 2019

Summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is voluntarily recalling 1,777 units of various sterile compounded medications, including injectable solutions, ophthalmic (eye) drops, and irrigation fluids. The recall was initiated because of a lack of assurance of sterility, which means the medications may contain contaminants like bacteria or fungi. These prescription products were distributed nationwide in the USA between early 2019 and August 2019 and include a wide range of vitamins, hormones like Testosterone and HCG, and eye treatments.

Risk

If a medication that is intended to be sterile is contaminated, it can lead to serious, life-threatening infections when injected or applied to the eyes. While no injuries have been reported to date, the lack of sterility assurance poses a significant health risk to patients using these compounded products.

What You Should Do

Check your medication packaging for the brand name 'Red Mountain Compounding Pharmacy' and verify if the product name and lot number match any of the approximately 100 affected items, such as S-ASCORBIC ACID (Lot S04112019DT@07), S-TESTOSTERONE CYP (Lot S02072019DT@08), or S-ATROPINE (Lot S06112019DH@22).
Immediately stop using any of the affected medications if they match the recalled lot numbers and expiration dates listed in the recall notice.
Contact your healthcare provider or pharmacist immediately to discuss alternative treatments and to report any side effects or concerns you may have after using these products.
Return any unused portions of the recalled medication to the pharmacy where you purchased it for a refund.
Contact Red Mountain Compounding Pharmacy directly at 6828 E Brown Rd Ste 101, Mesa, Arizona, for additional information regarding the return process.
For further questions about this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN (30ML)

Lot Numbers:

S06272019DT@08 (BUD: 9/27/2019)

Date Ranges: 9/27/2019

Product: S-ASCORBIC ACID 500MG/ML MDV SOLN (NON-CORN) (5ML, 30ML, 50ML)

Lot Numbers:

S04112019DT@07 (Exp 8/11/19)

S05012019DT@01 (Exp 9/1/19)

S05142019DT@13 (Exp 9/14/19)

S05282019DT@07 (Exp 9/28/19)

S06042019DT@05 (Exp 10/4/19)

S06182019DH@15 (Exp 10/18/19)

S07102019DT@13 (Exp 12/10/19)

S07172019DT@09 (Exp 12/17/19)

S04172019DT@01 (Exp 8/17/19)

Product: S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN (10ML)

Lot Numbers:

S07222019DH@09 (Exp 8/22/19)

Product: S-ATROPINE 0.01% OPHTHALMIC SOLUTION (10ML, 50ML)

Lot Numbers:

S06112019DH@22 (Exp 9/11/19)

S06202019DT@10 (Exp 9/20/19)

S07312019DH@07 (Exp 10/31/19)

S07302019DH@07 (Exp 10/30/19)

Product: S-ATROPINE 0.02% OPHTHALMIC SOLUTION (10ML)

Lot Numbers:

S05232019DH@03 (Exp 8/23/19)

S07172019DT@03 (Exp 10/17/19)

Product: S-ATROPINE 0.5% OPTH SOLN (10ML)

Lot Numbers:

S05232019DH@04 (Exp 8/23/19)

Product: S-B5/B6/B12M 100/50/10MG/ML MDV SOLN (30ML)

Lot Numbers:

S05132019DH@02 (Exp 8/13/19)

S05142019DT@05 (Exp 8/14/19)

S07032019DT@10 (Exp 10/3/19)

S07182019DH@01 (Exp 10/18/19)

Product: S-BENZALKONIUM CHLORIDE 0.013% SOLUTION (1000ML)

Lot Numbers:

S03142019DT@09 (Exp 9/14/19)

S05052019DH@04 (Exp 11/5/19)

S06192019DT@03 (Exp 12/19/19)

S06262019DT@12 (Exp 12/26/19)

Product: S-CALCIUM CHLORIDE 100MG/ML (PF) INJ SOLN (10ML)

Lot Numbers:

S07092019DT@14 (Exp 8/9/19)

Product: S-CALCIUM GLUCONATE 10% INJECTION (PF) (5ML, 10ML)

Lot Numbers:

03072019DH@08 (Exp 9/7/19)

S04042019DT@04 (Exp 10/4/19)

S05012019DH@04 (Exp 11/1/19)

S05242019DT@12 (Exp 11/24/19)

S06182019DH@12 (Exp 12/18/19)

S06182019DH@32 (Exp 12/18/19)

S07152019DH@02 (Exp 1/15/20)

S06202019DT@05 (Exp 12/20/19)

Product: S-CALM INJECTION (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) (10ML)

Lot Numbers:

S07312019DH@15 (Exp 8/31/19)

Product: S-CYANOCOBALAMIN 1,000 MCG/ML MDV INJ SOLN (10ML, 30ML)

Lot Numbers:

S05312019DT@03 (Exp 8/31/19)

S06032019DT@05 (Exp 9/3/19)

S06122019DT@07 (Exp 9/12/19)

S05312019DT@07 (Exp 8/31/19)

S06252019DH@11 (Exp 9/25/19)

S07172019DT@01 (Exp 10/25/19)

Product: S-DEXTROSE/GLYCERIN/PHENOL 25/25/2.5% INJ SOLN (30ML)

Lot Numbers:

S07292019DH@13 (Exp 8/29/19)

Product: S-DEXPANTHENOL 250MG/ML MDV INJ SOLN (30ML)

Lot Numbers:

S03072019DH@08 (Exp 9/7/19)

S02142019DH@08 (Exp 8/14/19)

S03072019DH@07 (Exp 9/7/19)

03072019DH@08 (Exp 9/7/19)

S03042019DH@07 (Exp 9/4/19)

S04172019DT@02 (Exp 10/17/19)

S05232019DT@10 (Exp 11/23/19)

S06242019DH@10 (Exp 12/24/19)

S07172019DT@07 (Exp 1/17/20)

S07242019DH@09 (Exp 1/24/20)

Product: S-DEXTROSE 50% MDV SOLN (50ML)

Lot Numbers:

S06092019DH@09 (Exp 9/9/19)

S06252019DT@11 (Exp 9/25/19)

S07092019DT@07 (Exp 10/9/19)

S07092019DT@13 (Exp 10/9/19)

Product: S-DMPS 50MG/ML INJ SOLN (PF) (5ML)

Lot Numbers:

S05092019DH@06 (Exp 8/9/19)

Product: S-DMSO 100% (PF) STERILE SOLUTION (10ML, 50ML)

Lot Numbers:

S04242019DT@15 (Exp 10/24/19)

S05012019DH@03 (Exp 11/1/19)

S05072019DT@10 (Exp 11/7/19)

S05072019DT@12 (Exp 11/7/19)

S06202019DT@03 (Exp 12/20/19)

S06202019DT@04 (Exp 12/20/19)

S07222019DH@05 (Exp 07/22/2019)

S06272019DT@06 (Exp 12/27/19)

Product: S-ESTRADIOL VALERATE 40MG/ML MDV INJ IN ETHYL OLEATE (5ML, 10ML)

Lot Numbers:

S06062019DH@03 (Exp 9/6/19)

S06182019DH@01 (Exp 9/18/19)

Product: S-TESTOSTERONE CYP 200MG/ML MDV IN ETHYL OLEATE OIL (5ML, 10ML, 13ML)

Lot Numbers:

S02072019DT@08 (Exp 9/7/19)

S02132019DH@06 (Exp 8/13/19)

S07312019DH@10 (Exp 1/31/20)

S06182019DH@23 (Exp 11/30/19)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83669

Status: Resolved

Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Sold By: Red Mountain Compounding Pharmacy

Manufactured In: United States

Units Affected: 94 products (2 x 30 mL vials; 81 vials; 2x 10 ml bottles; 6x10 ml, 1x50 ml dropper bottle; 2x10 ml dropper bottles; 1x10 ml dropper bottle; 5x10 ml glass vials; 4x1000 plastic containers; 1x10 glass vial; 18x10 ml and 1x5 ml glass vials; 5x10 ml and 5x30 ml glass vials; 8x30 ml glass vial; 37x30 ml glass vials; 5x50 ml glass vial; 1x5 ml glass vial; 10x50m ml and 1x10 ml glass vials; 1x10 glass vials; 2x10 ml glass vials; 3x50ml, 6x100ml glass vials; 11 5ml and 10ml glass vials; 2x5ml, 1x10 ml glass vials; 5x30 ml glass vials; 1 5ml bottle; 2 1L- bottles; 1, 3 ml prefilled syringe; 2x12 ML and 79x30 ML vials; 5x30 ML vials; 81 vials; 2x5 ml vials; 2x30 ml glass vials; 2x30 glass vials; 1x5 ml vial; 1x30 ml vial; 1x2ML syringe; 13x50 ml vials; 3x1 ml syringe; 1x30 ML vial; 2x30 ml vials; 2x10 ml vials; 60x 10 and 30 ML glass vials; 24x30 ml vials; 1x10ml glass vial; 3x10 ml glass vials; 1x5ml glass vial; 1x30 ml glass vial; 1x10ml droptainer; 38x30 ml glass vials; 2x5ml Glass vials; 3x10 ml glass vials; 11x10 ml glass vials; 3x30 ml glass vials; 13x5 and 10 ml glass vials; 1x5ml glass vial; 1x5ml glass vials; 2x30 ml glass vials; 1 vial; 16x5 and 10 ml glass vials; 22x10 ml glass vial; 1x50 ml plastic container; 7x10 ml dropper bottles; 10 50 ml vials; 1x5ml, 7x10ml, 3x11ml, glass vials; 2 5ml and 10 ml glass vials; 1x10, 1x30 ml glass vials; 8x10 ML vials; 11x 5ml and 10ml glass vials; 1x30 Ml glass vial; 16 5ml and 10ml glass vials; 6 vials; 135x30 ml glass vials; 2x30 ml glass vials; 28x30 ml glass vials; 108x 10 and 30 ml glass vials; 7x30 ml glass vials; 1x30 ml glass vial; 2x30ml glass vials; 1x5ml glass vial; 2x10ml glass vial; 91 x 5, 10, 13 ML glass vials; 1x5 ml glass vial; 1x5ml glass vial; 559 x 5, 10, 13 ml glass vials; 129x 5ml, 10ml, 13ml glass vials; 3x10 ml glass vials; 4x 10ml and 13 ml glass vials; 1x10 ml glass vials; 3x 10ml and 13 ml glass vials; 2x10 ml glass vials; 10x10 ml glass vial; 46 x30 ML glass vials; 1x5ml glass vial; 1x5 ml glass vial; 3x5ml glass vial; 34x5ml glass vial)

Distributed To: Nationwide

Agency Last Updated: November 14, 2019

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 · 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.

Summary

Risk

What You Should Do

Check your medication packaging for the brand name 'Red Mountain Compounding Pharmacy' and verify if the product name and lot number match any of the approximately 100 affected items, such as S-ASCORBIC ACID (Lot S04112019DT@07), S-TESTOSTERONE CYP (Lot S02072019DT@08), or S-ATROPINE (Lot S06112019DH@22).

Immediately stop using any of the affected medications if they match the recalled lot numbers and expiration dates listed in the recall notice.

Contact your healthcare provider or pharmacist immediately to discuss alternative treatments and to report any side effects or concerns you may have after using these products.

Return any unused portions of the recalled medication to the pharmacy where you purchased it for a refund.

Contact Red Mountain Compounding Pharmacy directly at 6828 E Brown Rd Ste 101, Mesa, Arizona, for additional information regarding the return process.

For further questions about this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN (30ML)

Lot Numbers:

S06272019DT@08 (BUD: 9/27/2019)

Date Ranges: 9/27/2019

Product: S-ASCORBIC ACID 500MG/ML MDV SOLN (NON-CORN) (5ML, 30ML, 50ML)

Lot Numbers:

S04112019DT@07 (Exp 8/11/19)

S05012019DT@01 (Exp 9/1/19)

S05142019DT@13 (Exp 9/14/19)

S05282019DT@07 (Exp 9/28/19)

S06042019DT@05 (Exp 10/4/19)

S06182019DH@15 (Exp 10/18/19)

S07102019DT@13 (Exp 12/10/19)

S07172019DT@09 (Exp 12/17/19)

S04172019DT@01 (Exp 8/17/19)

Product: S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN (10ML)

Lot Numbers:

S07222019DH@09 (Exp 8/22/19)

Product: S-ATROPINE 0.01% OPHTHALMIC SOLUTION (10ML, 50ML)

Lot Numbers:

S06112019DH@22 (Exp 9/11/19)

S06202019DT@10 (Exp 9/20/19)

S07312019DH@07 (Exp 10/31/19)

S07302019DH@07 (Exp 10/30/19)

Product: S-ATROPINE 0.02% OPHTHALMIC SOLUTION (10ML)

Lot Numbers:

S05232019DH@03 (Exp 8/23/19)

S07172019DT@03 (Exp 10/17/19)

Product: S-ATROPINE 0.5% OPTH SOLN (10ML)

Lot Numbers:

S05232019DH@04 (Exp 8/23/19)

Product: S-B5/B6/B12M 100/50/10MG/ML MDV SOLN (30ML)

Lot Numbers:

S05132019DH@02 (Exp 8/13/19)

S05142019DT@05 (Exp 8/14/19)

S07032019DT@10 (Exp 10/3/19)

S07182019DH@01 (Exp 10/18/19)

Product: S-BENZALKONIUM CHLORIDE 0.013% SOLUTION (1000ML)

Lot Numbers:

S03142019DT@09 (Exp 9/14/19)

S05052019DH@04 (Exp 11/5/19)

S06192019DT@03 (Exp 12/19/19)

S06262019DT@12 (Exp 12/26/19)

Product: S-CALCIUM CHLORIDE 100MG/ML (PF) INJ SOLN (10ML)

Lot Numbers:

S07092019DT@14 (Exp 8/9/19)

Product: S-CALCIUM GLUCONATE 10% INJECTION (PF) (5ML, 10ML)

Lot Numbers:

03072019DH@08 (Exp 9/7/19)

S04042019DT@04 (Exp 10/4/19)

S05012019DH@04 (Exp 11/1/19)

S05242019DT@12 (Exp 11/24/19)

S06182019DH@12 (Exp 12/18/19)

S06182019DH@32 (Exp 12/18/19)

S07152019DH@02 (Exp 1/15/20)

S06202019DT@05 (Exp 12/20/19)

Product: S-CALM INJECTION (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) (10ML)

Lot Numbers:

S07312019DH@15 (Exp 8/31/19)

Product: S-CYANOCOBALAMIN 1,000 MCG/ML MDV INJ SOLN (10ML, 30ML)

Lot Numbers:

S05312019DT@03 (Exp 8/31/19)

S06032019DT@05 (Exp 9/3/19)

S06122019DT@07 (Exp 9/12/19)

S05312019DT@07 (Exp 8/31/19)

S06252019DH@11 (Exp 9/25/19)

S07172019DT@01 (Exp 10/25/19)

Product: S-DEXTROSE/GLYCERIN/PHENOL 25/25/2.5% INJ SOLN (30ML)

Lot Numbers:

S07292019DH@13 (Exp 8/29/19)

Product: S-DEXPANTHENOL 250MG/ML MDV INJ SOLN (30ML)

Lot Numbers:

S03072019DH@08 (Exp 9/7/19)

S02142019DH@08 (Exp 8/14/19)

S03072019DH@07 (Exp 9/7/19)

03072019DH@08 (Exp 9/7/19)

S03042019DH@07 (Exp 9/4/19)

S04172019DT@02 (Exp 10/17/19)

S05232019DT@10 (Exp 11/23/19)

S06242019DH@10 (Exp 12/24/19)

S07172019DT@07 (Exp 1/17/20)

S07242019DH@09 (Exp 1/24/20)

Product: S-DEXTROSE 50% MDV SOLN (50ML)

Lot Numbers:

S06092019DH@09 (Exp 9/9/19)

S06252019DT@11 (Exp 9/25/19)

S07092019DT@07 (Exp 10/9/19)

S07092019DT@13 (Exp 10/9/19)

Product: S-DMPS 50MG/ML INJ SOLN (PF) (5ML)

Lot Numbers:

S05092019DH@06 (Exp 8/9/19)

Product: S-DMSO 100% (PF) STERILE SOLUTION (10ML, 50ML)

Lot Numbers:

S04242019DT@15 (Exp 10/24/19)

S05012019DH@03 (Exp 11/1/19)

S05072019DT@10 (Exp 11/7/19)

S05072019DT@12 (Exp 11/7/19)

S06202019DT@03 (Exp 12/20/19)

S06202019DT@04 (Exp 12/20/19)

S07222019DH@05 (Exp 07/22/2019)

S06272019DT@06 (Exp 12/27/19)

Product: S-ESTRADIOL VALERATE 40MG/ML MDV INJ IN ETHYL OLEATE (5ML, 10ML)

Lot Numbers:

S06062019DH@03 (Exp 9/6/19)

S06182019DH@01 (Exp 9/18/19)

Product: S-TESTOSTERONE CYP 200MG/ML MDV IN ETHYL OLEATE OIL (5ML, 10ML, 13ML)

Lot Numbers:

S02072019DT@08 (Exp 9/7/19)

S02132019DH@06 (Exp 8/13/19)

S07312019DH@10 (Exp 1/31/20)

S06182019DH@23 (Exp 11/30/19)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83669

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: Nationwide

Agency Last Updated: November 14, 2019