Agency classClass IIOur severity:Severe FDA (Drugs)·D-0218-2020·Announced 2019-11-13

Red Mountain Compounding Recalls S-Estradiol Cypionate Injections for Sterility Concerns

Red Mountain Compounding Pharmacy is recalling specific lots of S-Estradiol Cypionate 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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a significant risk of harm (lack of sterility in an injectable drug) corresponds to a severity score of 4 (Severe), as it implies a risk of adverse health consequences that are not merely theoretical or cosmetic.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Estradiol Cypionate 5mg/ml multi-dose vials. The affected products are packaged in 5ml and 10ml glass vials and are prescription-only. The recall involves a total of 11 vials across three specific lots: S05092019DH@08 (Exp 8/9/19), S06112019DH@14 (Exp 9/11/19), and S07222019DH@04 (Exp 10/22/19).

The recall was initiated due to a lack of assurance of sterility. The products were distributed nationwide in the USA. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the affected vials immediately. Patients who have received these injections should contact their healthcare provider for further instructions. The recalling firm is responsible for managing the recall and ensuring the products are removed from distribution.

The recalled product

Product: S-ESTRADIOL CYP 5MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10 ml, glass vials, Rx Only, Red Mountain Compounding RX
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Injectable Steroid
Hazard: sterility-failure
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 (6)

Lot #: S05092019DH@08
Exp 8/9/19
S06112019DH@14
Exp 9/11/19
S07222019DH@04
Exp 10/22/19

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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