Agency classClass IIOur severity:Severe FDA (Drugs)·D-0269-2020·Announced 2019-11-13

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.

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: 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
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Injectable Medication
Hazard: sterility
infection-risk

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.

See all 100 products in this recall →

Same manufacturer · First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

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