Class II · Moderate risk
Sodium Selinite 200mcg/Ml for Inj
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Mit/B12 25/50/50mg/Ml 1mg/Ml Mdv
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx
- Recalling firm
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Origin
- AZ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0065-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
All 2021 recalls
Class II · Moderate risk
Progesterone 100mg/Ml Mdv Oil Injection
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Mic/B12a/B6 15/50/100 5mg/50mg/Ml Mdv
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Mic/B12a 25/50/50mg/Ml 1mg/Ml Mdv
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Other sterility / contamination recalls from 2021
All sterility / contamination recalls
Class II · Moderate risk
Norepinephrine Bitartrate Injection USP 4 mg/4 mL
Lack of Assurance of Sterility
Class II · Moderate risk
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL
Lack of Assurance of Sterility
Class II · Moderate risk
Medroxyprogesterone Acetate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Vancomycin HCl in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
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