Pharmedium Recalls Subpotent Fentanyl Citrate Syringes Nationwide
Pharmedium Services, LLC is recalling 500 syringes of fentanyl citrate due to confirmed subpotency. The product was distributed nationwide.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Pharmedium Services, LLC is recalling 500 syringes of fentanyl citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only. The specific product code is 2R3174.
The recall was initiated because of confirmed subpotency in one lot of the product. The affected lot number is 15149004M, with an expiration date of 08/27/15. The product was distributed nationwide.
Healthcare providers and patients should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- 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 Number: 15149004M
- Exp 08/27/15
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.
See all 69 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 · subpotency
See all →- ModerateGood Neighbor Pharmacy Earwax Removal Drug Recalled for Low Potency
FDA (Drugs) · 2026-07-22
- ModerateNystatin Cream Recall Due to Low Potency Test Results
FDA (Drugs) · 2026-07-22
- ModerateFoster & Thrive Carbamide Peroxide 6.5% Recalled for Subpotent Strength
FDA (Drugs) · 2026-07-22
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- ModerateMeijer Earwax Removal Kit Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2026-07-22
Similar recalls
- CriticalPharmedium Recalls Subpotent Fentanyl Citrate Syringes for IV Use
FDA (Drugs) · 2016-02-24
- SeverePharmedium Recalls Sub-Potent Fentanyl and Ropivacaine Injection Syringes
FDA (Drugs) · 2018-12-26
- SeverePharMEDium Recalls Fentanyl Citrate Injection Lots for Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- CriticalCantrell Drug Recalls Subpotent Fentanyl Citrate Injection Syringes
FDA (Drugs) · 2016-07-13
- SeverePharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15