Agency classClass IIOur severity:Severe FDA (Drugs)·D-0262-2020·Announced 2019-11-13

Red Mountain Compounding Recalls S-Estradiol Cypionate Injections Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling specific lots of S-Estradiol Cypionate injections because the FDA identified 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling specific lots of S-Estradiol Cypionate 5mg/mL multi-dose vials. The product is packaged in 5ml, 10ml, and 11ml glass vials and is available by prescription only. The recall was initiated due to a lack of assurance of sterility.

The affected lots include S05092019DH@07, S05082019DT@11, S07032019DT@13, S07092019DT@09, and S07292019DH@03. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The product was distributed nationwide in the USA. Patients who have received these specific lots should contact their healthcare provider for guidance on next steps.

The recalled product

Product: S-ESTRADIOL CYP 5MG/ML MDV INJ IN SESAME OIL, packaged in a) 5ml, b) 10ml, c) 11ml, glass vials, Rx Only, Red Mountain Compounding RX.
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Injectable
Hazard: sterility

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 (10)

Lot #:S05092019DH@07
Exp 8/9/19
S05082019DT@11
Exp 8/8/19
S07032019DT@13
Exp 10/3/19
S07092019DT@09
Exp 10/9/19
S07292019DH@03
Exp 10/29/19

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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