Drug recall: S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX

Class II FDA enforcement event 83669. Recall start date: 12 Aug 2019. Status in the FDA record: Terminated. Termination date: 13 Apr 2023.

Reason for recall, in the words of FDA

Lack of Assurance of Sterility

Class II, in the words of FDA

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

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy started this drug recall on 12 Aug 2019. The firm address in the FDA record is in Mesa, AZ. FDA put the recall in Class II. FDA event 83669 has 100 product records. The first FDA enforcement report date is 13 Nov 2019. The record gives the status Terminated, with the termination date 13 Apr 2023.

FDA enforcement report The 100 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide in the USA

Recalling firm

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy, Mesa, AZ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

100 product records in the event.

FDA event 83669: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0198-2020	S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX	2 x 30 mL vials	Class II	Terminated	13 Nov 2019
D-0199-2020	S-ASCORBIC ACID 500MG/ML MDV SOLN (NON-CORN), packaged in a) 50ML, b) 5ML, c) 30ML, glass vial, RX Only, Red Mountain Compounding RX.	81 vials	Class II	Terminated	13 Nov 2019
D-0200-2020	S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 10ML dropper bottle, RX only, Red Mountain Compounding RX	2x 10 ml bottles	Class II	Terminated	13 Nov 2019
D-0201-2020	S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx only, Red Mountain Compounding RX.	6x10 ml, 1x50 ml dropper bottle	Class II	Terminated	13 Nov 2019
D-0202-2020	S-ATROPINE 0.02% OPTHALMIC SOLUTION, 10 ML dropper bottle, RX only, Red Mountain Compounding RX	2x10 ml dropper bottles	Class II	Terminated	13 Nov 2019
D-0203-2020	S-ATROPINE 0.5% OPTH SOLN, 10 ML dropper bottle, RX only, Red Mountain Compounding RX.	1x10 ml dropper bottle	Class II	Terminated	13 Nov 2019
D-0204-2020	S-B5/B6/B12M 100/50/10MG/ML MDV SOLN, 30ML glass vial, RX only, Red Mountain Compounding RX.	5x10 ml glass vials	Class II	Terminated	13 Nov 2019
D-0205-2020	S-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic container, For irrigation use only, Rx only, Red Mountain Compounding Rx.	4x1000 plastic containers	Class II	Terminated	13 Nov 2019
D-0206-2020	S-CALCIUM CHLORIDE 100MG/ML (PF) INJ SOLN, 10ml glass vial, Rx only, Red Mountain Compounding RX	1x10 glass vial	Class II	Terminated	13 Nov 2019
D-0207-2020	S-CALCIUM GLUCONATE 10% INJECTION (PF), packaged in a) 10 ml b) 5ml glass vials, Red Mountain Compounding RX	18x10 ml and 1x5 ml glass vials	Class II	Terminated	13 Nov 2019
D-0208-2020	S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV, 10 ml glass vial, Red Mountain Compounding Rx	N/A	Class II	Terminated	13 Nov 2019
D-0209-2020	S-CYANOCOBALAMIN 1,000 MCG/ML MDV INJ SOLN, packaged in a) 10ml and b) 30 ml glass vial, Rx Only, Red Mountain Compounding Rx.	5x10 ml and 5x30 ml glass vials	Class II	Terminated	13 Nov 2019
D-0210-2020	S-DEXTROSE/GLYCERIN/PHENOL 25/25/2.5% INJ SOLN, 30 ml glass vial, Rx Only, Red Mountain Compounding Rx	8x30 ml glass vial	Class II	Terminated	13 Nov 2019
D-0211-2020	S-DEXPANTHENOL 250MG/ML MDV INJ SOLN, 30ML glass vials, RX Only, Red Mountain Compounding RX	37x30 ml glass vials	Class II	Terminated	13 Nov 2019
D-0212-2020	S-DEXTROSE 50% MDV SOLN, 50 ML glass vial, RX Only, Red Mountain Compounding RX	5x50 ml glass vial	Class II	Terminated	13 Nov 2019
D-0213-2020	S-DMPS 50MG/ML INJ SOLN (PF), 5 ml glass vial, Rx Only, Red Mountain Compounding RX.	1x5 ml glass vial	Class II	Terminated	13 Nov 2019
D-0214-2020	S-DMSO 100% (PF) STERILE SOLUTION; packaged in a) 50 ml and b) 10 ml glass vials, Rx Only, Red Mountain Compounding Rx	10x50m ml and 1x10 ml glass vials	Class II	Terminated	13 Nov 2019
D-0215-2020	S-E2/TEST CYP 0.4MG/1MG/MLMDV IN OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain Compounding Rx.	1x10 glass vials	Class II	Terminated	13 Nov 2019
D-0216-2020	S-E2/TEST CYP 1MG/4MG SESAME OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain Compounding Rx.	2x10 ml glass vials	Class II	Terminated	13 Nov 2019
D-0217-2020	S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX.	3x50ml, 6x100ml glass vials	Class II	Terminated	13 Nov 2019
D-0218-2020	S-ESTRADIOL CYP 5MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10 ml, glass vials, Rx Only, Red Mountain Compounding RX	11 5ml and 10ml glass vials	Class II	Terminated	13 Nov 2019
D-0219-2020	S-ESTRADIOL VALERATE 20MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX.	2x5ml, 1x10 ml glass vials	Class II	Terminated	13 Nov 2019
D-0220-2020	S-FOLIC ACID 10MG/ML MDV INJ; packaged in 30ml glass vials, Rx Only, Red Mountain Compounding RX.	5x30 ml glass vials	Class II	Terminated	13 Nov 2019
D-0221-2020	S-GAT/KLAC/LIDO/PHE/TPMD 0.036/0.036/1.42/0.71/0.071%, OPTH GEL, 5ML dropper bottle, Red Mountain Compounding RX.	1 5ml bottle	Class II	Terminated	13 Nov 2019
D-0222-2020	S-GENTAMICIN 480MG/1L, IRRIGATION SOLN, 1000ML plastic bottle, Red Mountain Compounding Pharmacy	2 1L- bottles	Class II	Terminated	13 Nov 2019
D-0223-2020	S-GLUTATHIONE 200MG/3ML (PF) INHALATION SOLN, 3ML Prefilled Syringe, Red Mountain Compounding RX	1, 3 ml prefilled syringe	Class II	Terminated	13 Nov 2019
D-0224-2020	S-GLUTATHIONE 200MG/ML MDV, packaged in a) 12 ML b) 30 ml, glass vial, Red Mountain Compounding RX	2x12 ML and 79x30 ML vials	Class II	Terminated	13 Nov 2019
D-0225-2020	S-GLYCERIN 72% INJECTION SOLN, 30ML glass vial, Red Mountain Compounding RX	5x30 ML vials	Class II	Terminated	13 Nov 2019
D-0226-2020	S-HCG 1200U/ML MDV INJ SOLN; packaged in a) 5 ML, b) 10 ML, c) 30 ML glass vial. Red Mountain Compounding RX	81 vials	Class II	Terminated	13 Nov 2019
D-0227-2020	S-HYALURONIDASE 150U/ML INJ SOLN (PF), 5 ML vial, Red Mountain Compounding RX	2x5 ml vials	Class II	Terminated	13 Nov 2019
D-0228-2020	S-HYDROCHLORIC ACID 2MG/ML INJ SOLN, 50 ML glass vial, Red Mountain Compounding RX	N/A	Class II	Terminated	13 Nov 2019
D-0229-2020	S-HYDROGEN PEROXIDE 3% (PF) 30ML glass vial, Red Mountain Compounding RX	2x30 ml glass vials	Class II	Terminated	13 Nov 2019
D-0230-2020	S-HYDROXOCOBALAMIN 10MG/ML MDV INJ SOL, 30 ML glass vial, Red Mountain Compounding Rx.	2x30 glass vials	Class II	Terminated	13 Nov 2019
D-0231-2020	S-HYDROXYPROG CAPROATE 250MG/ML IN SESAME OIL INJ, 5ML glass vial, Red Mountain Compounding Rx	1x5 ml vial	Class II	Terminated	13 Nov 2019
D-0232-2020	S-LEVOCARNITINE 100MG/ML MDV INJ SOLN, 30ML vial, Red Mountain Compounding Rx	1x30 ml vial	Class II	Terminated	13 Nov 2019
D-0233-2020	S-LIDOCAINE HCL 2% INHALATION SOLN SYRINGES, 2ML syringe, Red Mountain Compounding Rx	1x2ML syringe	Class II	Terminated	13 Nov 2019
D-0234-2020	S-LIDOCAINE HCL 1% MDV SOLN, 50ML Vial, Red Mountain Compounding Rx	13x50 ml vials	Class II	Terminated	13 Nov 2019
D-0235-2020	S-LIDOCAINE HCL 1% / PHENYLEPHRINE1.5% (PF) INJ SOLN, 1ml syringe, Red Mountain Compounding Rx	3x1 ml syringe	Class II	Terminated	13 Nov 2019
D-0236-2020	S-LYSINE HCL 100MG/ML MDV, 30ML vial, Red Mountain Compounding Rx	1x30 ML vial	Class II	Terminated	13 Nov 2019
D-0237-2020	S-MAGNESIUM CHLORIDE 200MG/ML MDV INJ, 30 ml vial, Red Mountain Compounding Rx	N/A	Class II	Terminated	13 Nov 2019
D-0238-2020	S-MAGNESIUM SULFATE 500MG/ML (4MEQ/ML) MDV INJ SOLN, 30 ML vial, Red Mountain Compounding Rx	2x30 ml vials	Class II	Terminated	13 Nov 2019
D-0239-2020	S-MANGANESE CHLORIDE 0.1MG/ML MDV SOLN, 10 ML vial, Red Mountain Compounding Rx	2x10 ml vials	Class II	Terminated	13 Nov 2019
D-0240-2020	S-METHYLCOBALAMIN 1,000MCG/ML MDV INJ; a) 10ml, b) 30 ml glass vial, Rx Only, Red mountain Compounding RX	60x 10 and 30 ML glass vials	Class II	Terminated	13 Nov 2019
D-0241-2020	S-MIC 25/50/50MG/ML MDV SOLN, 30ml glass vial, Rx Only, Red Mountain Compounding RX.	24x30 ml vials	Class II	Terminated	13 Nov 2019
D-0242-2020	S-NANDROLONE DEC 200MG/ML MDV INJ in SESAME OIL, Rx Only, 10ml glass vial. Red Mountain Compounding Rx.	1x10ml glass vial	Class II	Terminated	13 Nov 2019
D-0243-2020	S-PHENOL 6% INJ SOLN, Rx Only 10ml glass vial, Red Mountain Compounding Rx.	3x10 ml glass vials	Class II	Terminated	13 Nov 2019
D-0244-2020	S-POTASSIUM CHLORIDE 2 MEQ/ML INJECTION CONC (PF) 5ml glass vial, Rx Only Red Mountain Compounding Rx.	1x5ml glass vial	Class II	Terminated	13 Nov 2019
D-0245-2020	S-PROCAINE HCL 1% BUFFERED MDV; Rx Only, 30ml glass vial Red Mountain Compounding Rx.	1x30 ml glass vial	Class II	Terminated	13 Nov 2019
D-0246-2020	S-PROGESTERONE/TESTOSTERONE 0.05%/0.03% OIL OPTH, Rx Only 10ml dropper bottle, Red Mountain Compounding Rx.	1x10ml droptainer	Class II	Terminated	13 Nov 2019
D-0247-2020	S-PYRIDOXINE HCL (B6) 100MG/ML MDV, Rx Only, 30ml glass vial. Red Mountain Compounding Rx.	38x30 ml glass vials	Class II	Terminated	13 Nov 2019
D-0248-2020	S-QUADMIX (30MG/2MG/20MCG/0.15MG/ML) MDV INJ, Rx Only, 5ml Glass vial. Red Mountain Compounding Rx.	2x5ml Glass vials	Class II	Terminated	13 Nov 2019
D-0249-2020	S-SOD CITRATE 4% INJ SOLN MDV, 10 ML glass vial, Red Mountain Compounding Rx	3x10 ml glass vials	Class II	Terminated	13 Nov 2019
D-0250-2020	S-SODIUM SELINITE 0.219% INJ, 19ml glass vials, Rx only, Red Mountain Compounding Rx	11x10 ml glass vials	Class II	Terminated	13 Nov 2019
D-0251-2020	S-TAURINE 50MG/ML MDV SOLN, Rx only 30ml glass vial, Red Mountain Compounding Rx	3x30 ml glass vials	Class II	Terminated	13 Nov 2019
D-0252-2020	S-TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10ml glass vials, Red Mountain Compounding Rx	13x5 and 10 ml glass vials	Class II	Terminated	13 Nov 2019
D-0253-2020	S-TESTOSTERONE HALF ULTRA 125MG/ML MDV IN SESAME OIL (TEST CYP 100MG/TEST PROP 12.5MG/NANDROLONE DECA 12.5), Rx Only, 5ML glass vial. Red Mountain Compounding Rx.	1x5ml glass vial	Class II	Terminated	13 Nov 2019
D-0254-2020	S-TRIMIX (15MG/0.5MG/10MCG/ML) INJ, Rx Only, 5ml glass vial, Red Mountain Compounding Rx.	1x5ml glass vials	Class II	Terminated	13 Nov 2019
D-0255-2020	S-VIT B COMPLEX (1/3/5/6/12A) MDV INJ 100/2/2/100/1MG/ML, 30 ML glass vial. Red Mountain Compounding Rx	2x30 ml glass vials	Class II	Terminated	13 Nov 2019
D-0256-2020	S-VIT A PALMITATE 50,000 IU/ML CORN OIL, Rx Only, 10ml dropper bottle. Red Mountain Compounding Rx.	1 vial	Class II	Terminated	13 Nov 2019
D-0257-2020	S-VITAMIN D3 10,000 IU/ML OIL MDV INJ, Rx Only, a) 5ml b) 10 ML glass vial. Red Mountain Compounding Rx.	16x5 and 10 ml glass vials	Class II	Terminated	13 Nov 2019

The table shows 60 of 100 product records. The FDA enforcement report lists all the records.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2019: 362
Share of these events in Class II: 68%
Product records in this event: 100Median of the firm: 100
Events of the firm on the register: 2

Other events of the firm

Other FDA enforcement events of First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Initiated	Product (first record)	Type	Class	Records
13 Aug 2021	Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx	Drug	Class II	40

Official channels

FDA enforcement report D-0198-2020The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 83669. https://recallregister.com/fda/ii/83669/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide in the USA
What quantity of product is in FDA event 83669?: The event has 100 product records. The first record gives this quantity: 2 x 30 mL vials
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2019 have the same class?: 68% of the 362 drug events that started in 2019 are in Class II.