Class II · Moderate risk
Progesterone Injection USP
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Progesterone 100mg/Ml Mdv Oil Injection
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
PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx
Drug: Progesterone
- 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-0066-2022 · 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 Progesterone recalls
See all
Class II · Moderate risk
Progesterone Injection
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Class II · Moderate risk
Progesterone 200 mg
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Class II · Moderate risk
Endometrin
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Progesterone-Gs Oil- 100mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Other recalls by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
All 2021 recalls
Class II · Moderate risk
Sodium Selinite 200mcg/Ml for Inj
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Mit/B12 25/50/50mg/Ml 1mg/Ml Mdv
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
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