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

FDA recall notice · announced November 3, 2021 · First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

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

Notes

Distribution: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
Lot/code information: all lots within expiry
Quantity: N/A
Status: Terminated
Products in this recall event:
- METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx (D-0058-2022)
- TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx (D-0046-2022)
- DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx (D-0036-2022)
- TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx (D-0043-2022)
- ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx (D-0037-2022)
- TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx (D-0050-2022)
- CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx (D-0035-2022)
- ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx (D-0031-2022)
- TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx (D-0042-2022)
- SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx (D-0067-2022)
- TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx (D-0048-2022)
- HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx (D-0039-2022)
- CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx (D-0034-2022)
- GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx (D-0038-2022)
- ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx (D-0053-2022)
- METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx (D-0059-2022)
- Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx (D-0029-2022)
- TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx (D-0047-2022)
- MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx (D-0065-2022)
- TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx (D-0044-2022)
- FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx (D-0057-2022)
- TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx (D-0045-2022)
- VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx (D-0051-2022)
- BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx (D-0055-2022)
- Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx (D-0028-2022)
- METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx (D-0061-2022)
- TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx (D-0049-2022)
- ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx (D-0033-2022)
- CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx (D-0056-2022)
- MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx (D-0062-2022)
- ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx (D-0032-2022)
- VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx (D-0052-2022)
- METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx (D-0060-2022)
- PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx (D-0066-2022)
- LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx (D-0040-2022)
- MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx (D-0064-2022)
- ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx (D-0054-2022)
- LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx (D-0030-2022)
- MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx (D-0063-2022)
- PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx (D-0041-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.