CLASS II Drug recall · Reported 13 Nov 2019 · FDA Enforcement Report

S-mic 25/50/50mg/ML B12a1mg/ML Mdv Inj Soln recalled

First Royal Care Co. LLC is recalling S-mic 25/50/50mg/ML B12a1mg/ML Mdv Inj Soln, distributed nationwide in the US. The recall was initiated on 12 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: a) S03272019DT@04, Exp 09/27/2019, b) S01302019DT@08, Exp 08/30/2019, S02192019DH@10, Exp 08/19/2019, S03072019DH@01, Exp 09/07/2019, S03042019DH@02, Exp 09/07/2019, S03272019DT@04, Exp 09/27/2019, S04172019DT@03, Exp 10/17/2019, S04302019DT@11, Exp 10/30/2019, S05162019DH@20, Exp 11/16/2019, S05292019DT@03, Exp 11/29/2019, S06252019DH@17, Exp 12/25/2019, S07172019DT@12, Exp 01/17/2020, S07182019DT@08, Exp 01/18/2020,

Quantity recalled108x 10 and 30 ml glass vials

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-0275-2020
FDA event ID: 83669
Recalling firm: First Royal Care Co. LLC, Mesa, AZ
Classification: Class II
Status: Terminated
Recall initiated: 12 Aug 2019
FDA classified: 5 Nov 2019
Reported: 13 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

12 Aug 2019	Recall initiated by company
5 Nov 2019	Classified by FDA	+85 days
13 Nov 2019	Published 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

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

S-MIC 25/50/50MG/ML B12A1MG/ML MDV INJ SOLN; Rx Only, a) 10ML b) 30ML glass vial. Red Mountain Compounding RX.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lot #: a) S03272019DT@04, Exp 09/27/2019, b) S01302019DT@08, Exp 08/30/2019, S02192019DH@10, Exp 08/19/2019, S03072019DH@01, Exp 09/07/2019, S03042019DH@02, Exp 09/07/2019, S03272019DT@04, Exp 09/27/2019, S04172019DT@03, Exp 10/17/2019, S04302019DT@11, Exp 10/30/2019, S05162019DH@20, Exp 11/16/2019, S05292019DT@03, Exp 11/29/2019, S06252019DH@17, Exp 12/25/2019, S07172019DT@12, Exp 01/17/2020, S07182019DT@08, Exp 01/18/2020,

Where was it sold?

Nationwide in the USA

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

99 other products · FDA event 83669

This product is part of a recall event; the main page for the event is S-hydrogen Peroxide 3% (PF) glass vial, Red Mountain Compounding RX recalled.

Reported	Class	Recall	Company	Reason	Where
13 Nov 2019	CLASS II	S-hydrogen Peroxide 3% (PF) glass vial, Red Mountain Compounding RX recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-procaine HCL 1% Buffered Mdv recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-calm Injection, (Mag S04/Gabapentin/Taurine/Theanine recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-lidocaine HCL 1% / PHENYLEPHRINE1.5% recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-sodium Selinite 0.219% Inj glass vials recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-trimix (15mg/0.5mg/10mcg/ML) Inj recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-methylcobalamin 1,000mcg/ML Mdv Inj recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-dextrose/Glycerin/Phenol 25/25/2.5% Inj Soln glass vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-test Cyp 125mg/ML Mdv In Ethyl Oleate Oil recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-methylcobalamin 25mg/ML Mdv Inj recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-mic 25/50/50 B12a 5mg/ML Mdv Soln recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-folic Acid 10mg/ML Mdv Inj recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-dmps 50MG/ML Inj Soln (PF) glass vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-testosterone Ultra 250mg/ML Mdv In Sesame Oil recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-zinc Sulfate !MG/ML Mdv Soln recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-gentamicin 480MG/, Irrigation Soln recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-vitamin D3 10,000 IU/ML Oil Mdv Inj recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-magnesium Chloride 200MG/ML Mdv Inj vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-hydroxocobalamin 10MG/ML MDV INJ SOL glass vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-methylcobalamin 5,000MCG/ML MDV Injection glass vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-MICB12C/Cartinine 25/50/50/1/50MG/ML MDV INJ recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-manganese Chloride 0.1MG/ML Mdv Soln vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-hydrochloric Acid 2MG/ML Inj Soln glass vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-atropine 0.01% Ophthalmic Solution recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-phenol 6% Inj Soln recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-mic 25/50/50MG/ML Mdv Soln glass vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-glycerin 72% Injection Soln glass vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-dexpanthenol 250MG/ML Mdv Inj Soln glass vials recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-hyaluronidase 150U/ML Inj Soln (PF) vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-test Cyp/nan-deca 200/50mg/ML Mdv In Sesame Oil recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-mic 25/50/50mg/ML Cyano 1mg/ML Mdv Soln recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-dmso 6.25% Opth Soln dropper recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-lidocaine HCL 2% Inhalation Soln Syringes syringe recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-vit B Complex (1/3/5/6/12A) Mdv Inj 100/2/2/100/1MG/ML glass vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-quadmix (30mg/2mg/20mcg/0.15mg/ML) Mdv Inj recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-methylcobalamin 10,000mcg/ML Mdv Inj recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-E2/Test Cyp 0.4MG/1MG/Mlmdv IN Oil Injection glass vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-hcg/b12a 1000u/5mg/ML Mdv Inj recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-hydroxocobalamin 1000mcg/ML Mdv Inj recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-dextrose 50% Mdv Soln glass vial recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-vit B Complex Inj Soln (hp) recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-lidocaine HCL 2% Mdv Inj Soln recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-testosterone Propionate 100mg/ML Mdv In Sesame Oil recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-glutathione 200MG/ (PF) Inhalation Soln Prefilled Syringe recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-pyridoxine HCL (b6) 100mg/ML Mdv recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-test Cyp/prop/deca-nan 250mg/ML (80/10/10) In Sesame Oil recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-magnesium Sulfate 500MG/ML (4MEQ/ML) Mdv Inj Soln vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-test Cyp 25mg/ML In Sesame Oil recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-edetate Disodium 15% Inj recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-glutathione 200mg/ML Mdv recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-estradiol Valerate 40mg/ML Mdv Inj In Ethyl Oleate recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-hydroxyprog Caproate 250mg/ML Oil Inj recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-potassium Chloride 2 Meq/ML Injection Conc (PF) glass vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-dmso 100% (pf) Sterile Solution recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-nandrolone Dec 200MG/ML Mdv Inj in Sesame Oil recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-test Cyp 100mg/ML In Ethyl Oleate Oil recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-sod Citrate 4% Inj Soln Mdv glass vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-test Cyp/prop 160/40mg/ML Mdv In Sesame Oil recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-hydroxyprog Caproate 250MG/ML IN Sesame Oil Inj glass recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-estradiol Cyp 5mg/ML Mdv Inj In Sesame Oil recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-taurine 50mg/ML Mdv Soln recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-hcg 3000 U/ML Mdv Soln glass vials recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-hcg 1200u/ML Mdv Inj Soln recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-ascorbic/Glutathione 1.25/1.25% Opth Soln dropper recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-trimix (15mg/0.5mg/16mcg/ML) Inj recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-calcium Chloride 100MG/ML (PF) Inj Soln glass vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-gat/Klac/Lido/Phe/Tpmd 0.036/0.036/1.42/0.71/0.071% recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-atropine 0.02% Opthalmic Solution dropper recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-ascorbic Acid 500mg/ML Mdv Soln (non-corn) recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-calcium Gluconate 1% Opth Irrigation recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-vit A Palmitate 50,000 IU/ML Corn Oil recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-procaine HCL 2% Buffered recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-test Cyp 50mg/ML Mdv In Ethyl Oleate Oil recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-test Cyp/prop 160/40mg/ML Mdv In Ethyl Oleate recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-calcium Gluconate 10% Injection (pf) recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-edetate Calcium 300mg/ML Inj Soln recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-benzalkonium Chloride 0.013% Solution, For irrigation use only recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-lidocaine HCL 1% Mdv Soln Vial, Red Mountain Compounding Rx recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-lysine HCL 100MG/ML MDV vial, Red Mountain Compounding Rx recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-B5/B6/B12M 100/50/10MG/ML MDV SOLN glass vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-trimix various strengths to include:a) S-trimix recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-cyanocobalamin 1,000 MCG/ML Mdv Inj Soln recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-testosterone Cyp 100MG/ML in Sesame Oil recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-mic/b12(c)/carnitine 25/50/50/1/50mg/ML Mdv Inj recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-folic Acid 20mg/ML Mdv Inj recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-estradiol Cyp 5mg/ML Mdv Inj In Ethyl Oleate recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-E2/Test Cyp 1MG/4MG Sesame Oil Injection glass vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-trimix (29.4mg/0.98mg/9.8mcg/ML) Inj recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-test Cyp 200mg/ML Mdv In Ethyl Oleate Oil recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-hydroxocoba 5000MCG/ML INJ glass vial, Red Mountain Compounding Rx recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-testosterone Half Ultra 125mg/ML Mdv In Sesame Oil recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-test Cyp 25mg/ML In Ethyl Oleate Oil Mdv recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-progesterone/testosterone 0.05%/0.03% Oil Opth recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-levocarnitine 100MG/ML Mdv Inj Soln vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-estradiol Valerate 20mg/ML Mdv Inj In Ethyl Oleate recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-atropine 0.5% Opth Soln dropper recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-amitriptyline 10MG/ML Mdv Inj Soln, glass vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-trimix (40mg/2.5mg/29mcg) Mdv Inj recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019	CLASS II	S-testosterone Cyp 200MG/ML Mdv In Sesame Oil recalled	First Royal Care Co. LLC	Sterility	Nationwide

More recalls from First Royal Care Co. LLC

All 140

Reported	Class	Recall	Company	Reason	Where
3 Nov 2021Drug	CLASS II	MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx recalled	First Royal Care Co. LLC	Sterility	7 states
3 Nov 2021Drug	CLASS II	Levocarnitine 100mg/ML Mdv Soln recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	7 states
3 Nov 2021Drug	CLASS II	Acetylcysteine 2% Opth Soln recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	7 states
3 Nov 2021Drug	CLASS II	Mic/b12a/b6 15/50/100 5mg/50mg/ML Mdv recalled	First Royal Care Co. LLC	Sterility	7 states
3 Nov 2021Drug	CLASS II	Levocarnitine 100mg/ML Mdv Soln recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	7 states

Other S-mic 25 recalls

All 4

Reported	Class	Recall	Company	Reason	Where
13 Nov 2019Drug	CLASS II	S-mic 25/50/50mg/ML Cyano 1mg/ML Mdv Soln recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019Drug	CLASS II	S-mic 25/50/50MG/ML Mdv Soln glass vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019Drug	CLASS II	S-mic 25/50/50 B12a 5mg/ML Mdv Soln recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide