Drug recall: Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
Class II FDA enforcement event 88693. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
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 13 Aug 2021. The firm address in the FDA record is in Mesa, AZ. FDA put the recall in Class II. FDA event 88693 has 40 product records. The first FDA enforcement report date is 3 Nov 2021. The record gives the status Terminated, with the termination date 12 Apr 2023.
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 . openFDA export of .
Distribution
In the words of FDA.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
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
40 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0028-2022 | Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0029-2022 | Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0030-2022 | LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0031-2022 | ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0032-2022 | ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0033-2022 | ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0034-2022 | CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0035-2022 | CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0036-2022 | DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0037-2022 | ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0038-2022 | GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0039-2022 | HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0040-2022 | LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0041-2022 | PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0042-2022 | TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0043-2022 | TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0044-2022 | TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0045-2022 | TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0046-2022 | TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0047-2022 | TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0048-2022 | TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0049-2022 | TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0050-2022 | TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0051-2022 | VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0052-2022 | VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0053-2022 | ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0054-2022 | ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0055-2022 | BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0056-2022 | CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0057-2022 | FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0058-2022 | METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0059-2022 | METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0060-2022 | METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0061-2022 | METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0062-2022 | MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0063-2022 | MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0064-2022 | MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0065-2022 | MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0066-2022 | PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
| D-0067-2022 | SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx | N/A | Class II | Terminated | 3 Nov 2021 |
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 2021
- 299
- Share of these events in Class II
- 60%
- Product records in this event
- 40Median of the firm: 100
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 12 Aug 2019 | S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX | Drug | Class II | 100 |
Official channels
- FDA enforcement report D-0028-2022The 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 88693. https://recallregister.com/fda/ii/88693/. Source: openFDA enforcement reports. Data through .
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:
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
- What quantity of product is in FDA event 88693?
- The event has 40 product records. The first record gives this quantity:
N/A
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2021 have the same class?
- 60% of the 299 drug events that started in 2021 are in Class II.