Red Mountain Compounding Recalls S-Hydroxyprogesterone Caproate Injections for Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Hydroxyprogesterone Caproate injections due to a lack of assurance of sterility.
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: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential contamination or sterility issues in injectable medications.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Hydroxyprogesterone Caproate 250mg/mL oil injections. The affected products are packaged in 5ml and 10ml glass vials. The recall was initiated due to a lack of assurance of sterility.
The recall involves 16 vials distributed nationwide in the USA. Specific lot numbers and expiration dates are listed in the official recall documentation. The agency has classified this recall as Class II.
Consumers who have these products should stop using them and contact their healthcare provider or the recalling pharmacy for instructions on how to proceed.
The recalled product
- Product
- S-HYDROXYPROG CAPROATE 250MG/ML OIL INJ, packaged in a) 5ML b) 10ML glass vial, Red Mountain Compounding Rx
- Category
- Drug — Injectable Medication
- Hazard
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 (9)
- Lot #:a) S06242019DH@07
- 9/24/19 b) S07222019DH@09
- Exp 10/22/19
- S05292019DT@06
- Exp 8/29/19
- S06032019DT@08
- Exp 9/3/19
- S06242019DH@07
- 9/24/19
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 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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