The Recall Desk
ModerateFDA (Drugs)·D-0072-2017·Announced 2016-10-19

Pharmedium Recalls Methadone Syringes Due to Potential Loss of Potency

Pharmedium Services, LLC is recalling 7,556 syringes of methadone HCl because stability data does not support the expiration dates, posing a risk of reduced drug potency.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a potential loss of potency without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Pharmedium Services, LLC is recalling 7,556 syringes of methadone HCl, 10 mg per mL, 1 mL Total Volume in a syringe, For IV Use Only. The product is identified by Product code 2T6149 and includes specific lot numbers with expiration dates ranging from 07/15/15 to 10/12/15.

The recall was initiated because stability data does not support the expiration dates for the drugs packaged and stored in syringes. This condition creates a potential for loss of potency in the medication.

The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled syringes and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
methadone HCl, 10 mg per mL, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6149.
Affected units
7,556

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 (20)

  • Lot Numbers: 15118069M
  • 15126004M
  • 151320095M
  • 15132023M
  • 15133005C
  • 15133011M
  • 15133032M
  • 15140003C
  • 15141005C
  • 15153010C
  • 151390098M
  • 15139065M
  • 15140074M
  • 151450122M
  • 15146010M
  • 15147052M
  • 15148046M
  • 15148058M
  • 15152062M
  • 15160001C

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 69 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 69 products in this recall →