Progesterone 100mg/ml Oil Injection Recall: Sterility Assurance Defect
Red Mountain Compounding Pharmacy is recalling Progesterone 100mg/ml MDV Oil Injection due to lack of assurance of sterility following FDA inspection. About 494 patients in seven states received prescriptions for this affected product.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a sterile injectable drug product with lack of sterility assurance. Class II recalls involve serious conditions where there is a potential for adverse health consequences or serious adverse events, and injectable products without assured sterility pose a significant risk of harm including infection and systemic complications.
Plain-English summary
Red Mountain Compounding Pharmacy (First Royal Care Co. LLC) is recalling Progesterone 100mg/ml MDV Oil Injection (Rx only). The recall was initiated due to lack of assurance of sterility, a concern raised during an FDA inspection of the compounding pharmacy.
Approximately 494 patients and consumers received prescriptions for this product. The affected individuals are located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All lots within expiry have been recalled.
Patients who have received this injection should consult their prescribing physician or healthcare provider for guidance. Patients with questions about this recall or their prescriptions should contact their healthcare provider or pharmacy directly.
The recalled product
- Product
- PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx
- Category
- Drug — Injectable / Compounded
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots within expiry
Distribution
Part of a larger recall action
This product is one of 40 recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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