The Recall Desk
SevereFDA (Drugs)·D-0435-2018·Announced 2018-02-28

Pharmedium Recalls Midazolam HCl in 5% Dextrose Due to Sterility Concerns

Pharmedium Services, LLC is recalling all lots of Midazolam HCl in 5% Dextrose due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging 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 in this case a critical sterility failure in an injectable medication, warrant a 'Severe' rating.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling all lots of Midazolam HCl in 5% Dextrose in all strengths, doses, and packaging. The recall is being conducted due to a lack of sterility assurance in the product.

The affected product is distributed nationwide in the United States. The recall includes all lots remaining within their expiration dates.

Consumers and healthcare providers should stop using the recalled product and contact Pharmedium Services, LLC for further instructions or a refund.

The recalled product

Product
Midazolam HCl in 5% Dextrose in all strengths, all doses, and all packaging.

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 (1)

  • All lots remaining within expiry.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 42 recalled by Pharmedium Services, LLC 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 42 products in this recall →