The Recall Desk
SevereFDA (Drugs)·D-0228-2020·Announced 2019-11-13

Red Mountain Compounding Recalls S-Hydrochloric Acid Injection Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling S-Hydrochloric Acid Injection due to a lack of assurance of sterility. The affected products were 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, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Hydrochloric Acid 2mg/mL Injection Solution, 50 mL glass vials. The recall was initiated because there is a lack of assurance of sterility for the affected products.

The recall covers two specific lots: S06092019DH@03 with an expiration date of 9/9/19, and S06162019DH@17 with an expiration date of 9/16/19. These products were distributed nationwide in the United States.

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

The recalled product

Product
S-HYDROCHLORIC ACID 2MG/ML INJ SOLN, 50 ML 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 #: S06092019DH@03
  • Exp 9/9/19
  • S06162019DH@17
  • Exp 9/16/19

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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