The Recall Desk
SevereFDA (Drugs)·D-0070-2017·Announced 2016-10-19

Pharmedium Recalls Methadone Syringes Due to Stability Data Concerns

Pharmedium Services, LLC is recalling 7,006 syringes of methadone HCl because stability data does not support the expiration dates, posing a risk of reduced potency.

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 FDA classified this recall as Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant risks such as loss of potency in a potent medication like methadone.

Plain-English summary

Pharmedium Services, LLC is recalling 7,006 syringes of methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride. The product is packaged in 1 mL syringes for intravenous use only. The recall is being conducted because stability data does not support the expiration dates for the drugs packaged and stored in syringes.

The affected product is identified by Product code 2T6120. Specific lot numbers include 15118004M, 15119082M, 15134004C, 15134006M, 15139004C, 15139011M, 15140071M, 15141001M, 15141129M, 15147012C, 15147030M, 15148004C, 15150021M, 15155002C, 15160002C, 15160006C, 151730013C, 151760016C, 151810002C, and 151890129M. The expiration dates for these lots range between 07/15/15 and 10/12/15. The product was distributed nationwide.

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 primary hazard is a potential loss of potency in the medication. Consumers and healthcare providers should stop using the affected syringes and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6120.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
7,006

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: 15118004M
  • 15119082M
  • 15134004C
  • 15134006M
  • 15139004C
  • 15139011M
  • 15140071M
  • 15141001M
  • 15141129M
  • 15147012C
  • 15147030M
  • 15148004C
  • 15150021M
  • 15155002C
  • 15160002C
  • 15160006C
  • 151730013C
  • 151760016C
  • 151810002C
  • 151890129M

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 →

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