CLASS II Drug recall · Reported 3 Nov 2021 · FDA Enforcement Report

Levocarnitine 100mg/ML Mdv Soln recalled by First Royal Care Co. LLC

First Royal Care Co. LLC is recalling Levocarnitine 100mg/ML Mdv Soln, distributed in 7 states. The recall was initiated on 13 Aug 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall lots within expiry
Quantity recalledN/A

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0030-2022
FDA event ID
88693
Recalling firm
First Royal Care Co. LLC, Mesa, AZ
Classification
Class II
Status
Terminated
Recall initiated
13 Aug 2021
FDA classified
26 Oct 2021
Reported
3 Nov 2021
Type
Voluntary: Firm initiated
Customers notified by
N/A
Reason category
Sterility

Timeline

13 Aug 2021Recall initiated by company
26 Oct 2021Classified by FDA+74 days
3 Nov 2021Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx

Where it was distributed

494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

ArizonaCaliforniaFloridaMinnesotaMontanaTexasUtah

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Which lots are affected?

all lots within expiry

Where was it sold?

494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

39 other products · FDA event 88693

This product is part of a recall event; the main page for the event is Pyridoxine HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIPyridoxine HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx recalledFirst Royal Care Co. LLCSterility7 states
CLASS IIMethylcobalamin 10,000mcg/ML Mdv Inj recalledFirst Royal Care Co. LLCSterility7 states
CLASS IITest Cyp 50mg/ML In Ethyl Oleate Oil recalledFirst Royal Care Co. LLCSterility7 states
CLASS IIDexpanthenol 250mg/ML Inj Soln recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
CLASS IITest Cyp 200mg/ML In Sesame Oil Mdv recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
CLASS IIEstradiol Valerate 5mg/ML Mdv Inj recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
CLASS IITestosterone Ultra 250mg/ML Mdv In Sesame Oil recalledFirst Royal Care Co. LLCSterility7 states
CLASS IICyclosporine 2% Mct Oil Susp recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
CLASS IIAscorbic Acid (non-corn) 500mg/ML Mdv Soln recalledFirst Royal Care Co. LLCSterility7 states
CLASS IITest Cyp 100mg/ML In Ethyl Oleate Oil recalledFirst Royal Care Co. LLCSterility7 states
CLASS IISodium Selinite 200mcg/ML For Inj recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
CLASS IITest Cyp/prop/deca-nan 125mg/ML (80/10/10) In Sesame Oil recalledFirst Royal Care Co. LLCSterility7 states
CLASS IIHydroxyprog Caproate 250mg/ML Oil Inj recalledFirst Royal Care Co. LLCSterility7 states
CLASS IICyclosporin 0.2% Oil Opth Susp recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
CLASS IIGlutathione 200mg/ML Mdv recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
CLASS IIAcetylcysteine 10% Opth Soln, Red Mountain Compounding Rx recalledFirst Royal Care Co. LLCSterility7 states
CLASS IIMethylcobalamin 1000mcg/ML Mdv Inj recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
CLASS IIMagnesium Chloride, 200 mg/mL MDV INJ recalledFirst Royal Care Co. LLCSterility7 states
CLASS IITest Cyp/prop 160/40mg/ML Mdv In Ethyl Oleate recalledFirst Royal Care Co. LLCSterility7 states
CLASS IIMit/b12 25/50/50mg/ML 1mg/ML Mdv recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
CLASS IITest Cyp 200mg/ML Mdv Ethyl Oleate recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
CLASS IIFolic Acid 10mg/ML Mdv Inj recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
CLASS IITest Cyp 25mg/ML In Ethyl Oleate Mdv recalledFirst Royal Care Co. LLCSterility7 states
CLASS IIVit B Complex Inj Soln (hp) recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
CLASS IIBenzalkonium Chloride 0.013% Solution recalledFirst Royal Care Co. LLCSterility7 states
CLASS IICalcium Chloride, 100 mg/mL MDV INJ recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
CLASS IIMethylcobalamin 5000mcg/ML Mdv Inj recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
CLASS IITest Cyp/prop/deca-nan 125mg/ML (80/10/10) In Sesame Oil recalledFirst Royal Care Co. LLCSterility7 states
CLASS IIAscorbic/glutathione 1.25/1.25% Opth Soln recalledFirst Royal Care Co. LLCSterility7 states
CLASS IICalcium Gluconate 10% Inj (pf) recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
CLASS IIMic 25/50/50mg/ML Mdv recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
CLASS IIAscorbic Acid (non-corn) 500mg/ML Soln (pf) recalledFirst Royal Care Co. LLCSterility7 states
CLASS IIVit B Complex Inj Soln (hp) recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
CLASS IIMethylcobalamin 12.5mg/ML Mdv Inj Soln recalledFirst Royal Care Co. LLCSterility7 states
CLASS IIProgesterone 100mg/ML Mdv Oil Injection recalledFirst Royal Care Co. LLCSterility7 states
CLASS IILevocarnitine 100mg/ML Mdv Soln recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
CLASS IIMic/b12a/b6 15/50/100 5mg/50mg/ML Mdv recalledFirst Royal Care Co. LLCSterility7 states
CLASS IIAcetylcysteine 2% Opth Soln recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
CLASS IIMIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx recalledFirst Royal Care Co. LLCSterility7 states

More recalls from First Royal Care Co. LLC

All 140
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIMIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx recalledFirst Royal Care Co. LLCSterility7 states
DrugCLASS IIAcetylcysteine 2% Opth Soln recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
DrugCLASS IIMic/b12a/b6 15/50/100 5mg/50mg/ML Mdv recalledFirst Royal Care Co. LLCSterility7 states
DrugCLASS IILevocarnitine 100mg/ML Mdv Soln recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
DrugCLASS IIProgesterone 100mg/ML Mdv Oil Injection recalledFirst Royal Care Co. LLCSterility7 states

Other Levocarnitine recalls

All 9
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIILevocarnitine Injection, USP (200 mg/mL) Single-Dose Vial recalledLevocarnitineAmerican RegentLabeling ErrorsNationwide
DrugCLASS IILevocarnitine Oral Solution recalled by AkornAkornPotency & AssayNationwide
DrugCLASS IILevocarnitine 500mg/mL-vial, Refrigerate, Tailor Made Compounding recalledTMC AcquisitionSterilityNationwide
DrugCLASS IILevocarnitine 100mg/ML Mdv Soln recalled by First Royal Care Co. LLCFirst Royal Care Co. LLCSterility7 states
DrugCLASS IILevocarnitine Injection, Levocarnitine 500 MG/ML Injectable recalledFusion IV PharmaceuticalsSterilityNationwide