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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88693

40 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 13, 2021
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

40 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 40

Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx

D-0028-2022
Recall number
D-0028-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 2 of 40

Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx

D-0029-2022
Recall number
D-0029-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 3 of 40

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

D-0030-2022
Recall number
D-0030-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 4 of 40

ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx

D-0031-2022
Recall number
D-0031-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 5 of 40

ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx

D-0032-2022
Recall number
D-0032-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 6 of 40

ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx

D-0033-2022
Recall number
D-0033-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 7 of 40

CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx

D-0034-2022
Recall number
D-0034-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 8 of 40

CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx

D-0035-2022
Recall number
D-0035-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 9 of 40

DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx

D-0036-2022
Recall number
D-0036-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 10 of 40

ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

D-0037-2022
Recall number
D-0037-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 11 of 40

GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx

D-0038-2022
Recall number
D-0038-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 12 of 40

HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx

D-0039-2022
Recall number
D-0039-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 13 of 40

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

D-0040-2022
Recall number
D-0040-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 14 of 40

PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx

D-0041-2022
Recall number
D-0041-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 15 of 40

TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx

D-0042-2022
Recall number
D-0042-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 16 of 40

TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx

D-0043-2022
Recall number
D-0043-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 17 of 40

TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx

D-0044-2022
Recall number
D-0044-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 18 of 40

TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx

D-0045-2022
Recall number
D-0045-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 19 of 40

TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx

D-0046-2022
Recall number
D-0046-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 20 of 40

TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx

D-0047-2022
Recall number
D-0047-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 21 of 40

TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx

D-0048-2022
Recall number
D-0048-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 22 of 40

TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx

D-0049-2022
Recall number
D-0049-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 23 of 40

TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx

D-0050-2022
Recall number
D-0050-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 24 of 40

VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx

D-0051-2022
Recall number
D-0051-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 25 of 40

VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx

D-0052-2022
Recall number
D-0052-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 26 of 40

ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx

D-0053-2022
Recall number
D-0053-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 27 of 40

ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx

D-0054-2022
Recall number
D-0054-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 28 of 40

BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx

D-0055-2022
Recall number
D-0055-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 29 of 40

CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx

D-0056-2022
Recall number
D-0056-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 30 of 40

FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

D-0057-2022
Recall number
D-0057-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 31 of 40

METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

D-0058-2022
Recall number
D-0058-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 32 of 40

METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

D-0059-2022
Recall number
D-0059-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 33 of 40

METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx

D-0060-2022
Recall number
D-0060-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 34 of 40

METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

D-0061-2022
Recall number
D-0061-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 35 of 40

MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx

D-0062-2022
Recall number
D-0062-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 36 of 40

MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx

D-0063-2022
Recall number
D-0063-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 37 of 40

MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx

D-0064-2022
Recall number
D-0064-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 38 of 40

MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx

D-0065-2022
Recall number
D-0065-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 39 of 40

PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx

D-0066-2022
Recall number
D-0066-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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

drug · product 40 of 40

SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx

D-0067-2022
Recall number
D-0067-2022
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

all lots within expiry

Distribution pattern

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