Pharmedium Recalls Remifentanil Syringes Due to Potential Loss of Potency
Pharmedium Services, LLC is recalling 1,623 syringes of remifentanil HCl because stability data does not support the expiration dates, posing a risk of reduced drug potency.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 voluntary precautionary recall.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling 1,623 syringes of remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe. The product is prescription-only and was distributed nationwide.
The recall is being conducted 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 lot numbers are 151680012C, 151720013C, 151730179M, 151740029M, 151790014C, 151880319M, 151890297M, 151890318M, 151900127M, and 151930081M. These lots have expiration dates between 07/15/15 and 10/12/15. Healthcare providers and patients should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description.
The recalled product
- Product
- remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3300.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,623
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 (11)
- Lot Numbers: 151680012C
- 151720013C
- 151730179M
- 151740029M
- 151790014C
- 151880319M
- 151890297M
- 151890318M
- 151900127M
- 151930081M
- 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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