The Recall Desk
SevereFDA (Drugs)·D-0238-2020·Announced 2019-11-13

Red Mountain Compounding Recalls Magnesium Sulfate Injection Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling specific vials of Magnesium Sulfate Injection because the FDA determined there is 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 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 2x30 ml vials of S-MAGNESIUM SULFATE 500MG/ML (4MEQ/ML) MDV INJ SOLN. The recall is being conducted due to a lack of assurance of sterility in the product.

The affected product is identified by Lot # S06192019DT@04 and has an expiration date of 9/19/19. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

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-MAGNESIUM SULFATE 500MG/ML (4MEQ/ML) MDV INJ SOLN, 30 ML 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 #: S06192019DT@04
  • Exp 9/19/19

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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