The Recall Desk
SevereFDA (Drugs)·D-0215-2020·Announced 2019-11-13

Red Mountain Compounding Recalls S-E2/TEST CYP Injection Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling S-E2/TEST CYP 0.4MG/1MG/MLMDV IN OIL INJECTION vials 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury.

Plain-English summary

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy, is recalling S-E2/TEST CYP 0.4MG/1MG/MLMDV IN OIL INJECTION, 10 ml glass vials. The recall is being conducted because of a lack of assurance of sterility for the product.

The affected product is identified by Lot # S06262019DT@08 and has an expiration date of 9/26/19. The recall is classified as Class II by the U.S. Food and Drug Administration. The product was distributed nationwide in the USA.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
S-E2/TEST CYP 0.4MG/1MG/MLMDV IN OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain Compounding Rx.

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 (2)

  • Lot #: S06262019DT@08
  • Exp 9/26/19

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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