The Recall Desk
SevereFDA (Drugs)·D-0292-2020·Announced 2019-11-13

Red Mountain Compounding Recalls S-Testosterone Ultra Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling S-Testosterone Ultra 250mg/ml vials because the product lacks 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, which corresponds to a Severe severity score under the rubric for drug recalls involving potential serious health consequences.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling specific lots of S-Testosterone Ultra 250mg/ml MDV in Sesame Oil. The recall is being conducted because the product lacks assurance of sterility.

The affected product is a prescription-only medication packaged in 10ml glass vials. The recall covers lots S07132019DT@01, S07312019DH@05, and S06122019DT@09. These products were distributed nationwide in the USA.

Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
S-TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL (TEST CYP 200MG/TEST PROP 25MG/NANDROLONE DECA 25MG) 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 (5)

  • Lot #:S07132019DT@01
  • Exp 10/13/19
  • S07312019DH@05
  • Exp 10/31/19 S06122019DT@09
  • Exp 9/12/19

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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