The Recall Desk
SevereFDA (Drugs)·D-0229-2020·Announced 2019-11-13

Red Mountain Compounding Pharmacy Recalls Hydrogen Peroxide Vials for Sterility Concerns

Red Mountain Compounding Pharmacy is recalling specific lots of 3% hydrogen peroxide 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, which corresponds to a Severe severity score under the rubric for potential serious temporary or medically reversible health consequences.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling 2x30 ml glass vials of S-HYDROGEN PEROXIDE 3% (PF). The recall is being conducted because of a lack of assurance of sterility in the product.

The affected product includes two specific lots: S05082019DT@02 with an expiration date of 8/8/19, and S05112019DH@17 with an expiration date of 8/11/19. These products were distributed nationwide in the USA.

Consumers who have these specific lots of hydrogen peroxide should stop using them and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
S-HYDROGEN PEROXIDE 3% (PF) 30ML 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 (4)

  • Lot #: S05082019DT@02
  • Exp 8/8/19
  • S05112019DH@17
  • Exp 8/11/19

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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