Hydroxyprogesterone Caproate Injection Recalled Due to Sterility Concerns
First Royal Care Compounding Pharmacy is recalling Hydroxyprogesterone Caproate 250 mg/mL oil injection due to lack of assurance of sterility identified during FDA inspection. The drug was distributed to patients in seven states.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of an injectable drug with a sterility defect. Class II recalls with drug safety risks warrant a Severe classification per the rubric, as contamination in sterile injectable products poses serious health risks including infection and systemic complications.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling Hydroxyprogesterone Caproate 250 mg/mL oil injection for Rx use only. The FDA conducted an inspection that raised concerns about the product's sterility assurance.
Approximately 494 patients received prescriptions for this product. Distribution occurred across Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All lots within their expiration dates are affected by this recall.
Consumers who have received this medication should consult with their healthcare provider or pharmacist regarding whether they need to take any action. The FDA is working with the manufacturer on this Class II recall.
The recalled product
- Product
- HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx
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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