Pharmedium Recalls Methadone Syringes Due to Potential Loss of Potency
Pharmedium Services, LLC is recalling 200 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, and the hazard is a potential loss of potency without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Pharmedium Services, LLC is recalling 200 syringes of methadone HCl, 2.5 mg per 0.5 mL, in 0.9% Sodium Chloride. The product is packaged in 0.5 mL syringes for intravenous use only and is available by prescription. The recall covers specific lot numbers: 15149041M, 151720043M, 15100060M, and 15127064M, with expiration dates ranging from July 15, 2015, to October 12, 2015.
The recall was initiated because stability data does not support the expiration dates for the drugs packaged and stored in syringes. This condition may result in a potential loss of potency in the medication. The affected product was distributed nationwide.
Healthcare providers and patients should stop using the affected methadone syringes and contact Pharmedium Services, LLC for further instructions or replacement. Consumers should verify the lot numbers and expiration dates against the recall notice to determine if their product is affected.
The recalled product
- Product
- methadone HCl, 2.5 mg per 0.5 mL, in 0.9% Sodium Chloride, 0.5 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6134.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 200
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 (5)
- Lot Numbers: 15149041M
- 151720043M
- 15100060M
- 15127064M
- Exp between 07/15/15-10/12/15
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.
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