The Recall Desk
SevereFDA (Drugs)·D-0461-2018·Announced 2018-02-28

Pharmedium Recalls Neostigmine Methylsulfate Injection Due to Sterility Concerns

Pharmedium Services, LLC is recalling all lots of Neostigmine Methylsulfate Injection due to a lack of sterility assurance.

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 agency classified this as an FDA Class II recall. Under the rubric, FDA Class II recalls involving significant risks such as sterility failures in injectable drugs are categorized as Severe.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling Neostigmine Methylsulfate Injection in all strengths, doses, and packaging. The recall is being conducted because of a lack of sterility assurance for the product.

The affected product is distributed nationwide in the United States. The recall includes all lots remaining within their expiration dates. No specific lot numbers or quantities are listed in the source text.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions on how to return or dispose of the medication.

The recalled product

Product
Neostigmine Methylsulfate Injection 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 →