The Recall Desk
SevereFDA (Drugs)·D-0093-2017·Announced 2016-10-19

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
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 →