The Recall Desk
SevereFDA (Drugs)·D-0242-2020·Announced 2019-11-13

Red Mountain Compounding Recalls S-Nandrolone Decanoate Injections for Sterility Concerns

Red Mountain Compounding Pharmacy is recalling S-Nandrolone Decanoate injections due to a lack of assurance of sterility. The affected lot is distributed nationwide.

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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. While specific injury reports are not detailed in the provided text, the agency classification of Class II for a sterility issue in an injectable drug aligns with the Severe criteria for significant risk.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Nandrolone Decanoate 200mg/mL multi-dose vials in sesame oil. The recall is being conducted because of a lack of assurance of sterility for the product.

The affected product is identified by Lot # S07022019DT@02 with an expiration date of 10/2/19. The product is a prescription-only medication packaged in 10ml glass vials. The recall covers distribution nationwide in the USA.

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

The recalled product

Product
S-NANDROLONE DEC 200MG/ML MDV INJ in SESAME OIL, Rx Only, 10ml glass vial. 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 #: S07022019DT@02
  • Exp 10/2/19

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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