Pharmedium Recalls Subpotent Fentanyl Citrate Syringes for IV Use
Pharmedium Services, LLC is recalling 180 syringes of fentanyl citrate because the drug was subpotent. The affected product was distributed to nine hospital pharmacies.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies 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 180 syringes of fentanyl citrate, preservative free, 5 mcg per mL in 0.9% sodium chloride, 1 mL total volume for IV use. The product is packaged in a 3 mL syringe and carries the code 2R3479. The specific lot number is 15002077M, with an expiration date of 04-02-2015.
The recall was initiated because the drug was found to be subpotent, meaning it contained less than the labeled amount of the active ingredient. 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 the firm notified the affected parties by telephone. The recall status is listed as Terminated as of February 22, 2016.
The recalled product
- Product
- fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3479, PharMEDium.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 180
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 #: 15002077M
- 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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