The Recall Desk
SevereFDA (Drugs)·D-0466-2018·Announced 2018-02-28

Pharmedium Recalls Methadone HCl Injection Due to Sterility Concerns

Pharmedium Services, LLC is recalling Methadone HCl Injection in all strengths and packaging 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in an injectable medication.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling Methadone HCl Injection in all strengths, all doses, and all 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 of the medication that are remaining within their expiration dates.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions or to obtain a replacement.

The recalled product

Product
Methadone HCl 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 →