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.
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 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Pharmedium Services, LLC
See all →- SeverePharMEDium Recalls nICARdipine HCl Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Infusions Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
Same hazard · subpotent drug
See all →- LowImprimisRx Recalls Subpotent Povidone Iodine and Proparacaine Ophthalmic Solution
FDA (Drugs) · 2026-09-16
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- SevereAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets
FDA (Drugs) · 2026-09-02
Similar recalls
- SeverePharmedium Recalls Subpotent Fentanyl Citrate Syringes Nationwide
FDA (Drugs) · 2016-10-19
- SeverePharmedium Recalls Fentanyl Syringes Due to Potential Loss of Potency
FDA (Drugs) · 2016-10-19
- SeverePharmedium Recalls Fentanyl Syringes Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19
- SeverePharmedium Recalls Fentanyl Citrate Injection Due to Subpotency and Stability Issues
FDA (Drugs) · 2016-10-19
- ModeratePharmedium Recalls Fentanyl Citrate Syringes Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19
- ModerateFentanyl Citrate Injection Recalled Due to Potential Loss of Potency
FDA (Drugs) · 2016-10-19