Pharmedium Recalls Subpotent Fentanyl Citrate Syringes for IV Use
Pharmedium Services, LLC is recalling 500 syringes of fentanyl citrate because the drug was subpotent. The affected product was distributed to nine hospital pharmacies.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly classifies the recall as FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling 500 syringes of fentanyl citrate, preservative free, 10 mcg per 1 mL in 0.9% sodium chloride, 1 mL total volume for IV use. The product is packaged in a 3 mL syringe with code 2R3174. The specific lot number is 15002250M, with an expiration date of 04-02-2015.
The recall was initiated because the drug was found to be subpotent, meaning it contained less of the active ingredient than labeled. This classification is designated as Class I by the FDA, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.
The affected product was distributed to nine specific hospital pharmacies located in Virginia, Iowa, Wisconsin, Colorado, California, Pennsylvania, and Oklahoma. The recall was initiated on January 13, 2015, and was terminated on February 22, 2016. Consumers and healthcare providers should check their inventory for this specific lot number and stop using the product if found.
The recalled product
- Product
- fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3174, PharMEDium
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 500
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 (2)
- Lot #: 15002250M
- Exp 04-02-2015
Distribution
Part of a larger recall action
This product is one of 2 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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