Agency classClass IIOur severity:Severe FDA (Drugs)·D-0265-2020·Announced 2019-11-13

Red Mountain Compounding Recalls S-HCG 3000 U/ML Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling S-HCG 3000 U/ML vials because the FDA determined there is 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 classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a medical product, which aligns with the rubric criteria for Severe severity involving significant injury risks or Class II classifications with potential for serious harm.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-HCG 3000 U/ML MDV SOLN, 10 ML glass vials. The recall was initiated due to a lack of assurance of sterility in the product.

The affected product is prescription-only and was distributed nationwide in the USA. The recall covers 8x10 ML vials from specific lots: S06272019DT@07 (Exp 8/27/19), S07262019DH@04 (Exp 9/26/19), and S07302019DH@04 (Exp 9/30/19).

Consumers should check their medication for these specific lot numbers and expiration dates. If the product matches the recalled description, they should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.

The recalled product

Product: S-HCG 3000 U/ML MDV SOLN, 10 ML glass vials, Rx Only, Red Mountain Compounding Rx.
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Compounded Medication
Hazard: sterility
infection

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 (6)

Lot #: S06272019DT@07
Exp 8/27/19
S07262019DH@04
Exp 9/26/19
S07302019DH@04
Exp 9/30/19

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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