The Recall Desk
SevereFDA (Drugs)·D-0034-2017·Announced 2016-10-19

Pharmedium Recalls Fentanyl Citrate Injection Due to Subpotency and Stability Issues

Pharmedium Services, LLC is recalling specific lots of fentanyl citrate injection because confirmed subpotency and stability data do not support the expiry date.

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 recall is classified as FDA Class II and involves a potent opioid medication with confirmed subpotency, which poses a significant risk of therapeutic failure or adverse outcomes, meeting the criteria for a Severe rating.

Plain-English summary

Pharmedium Services, LLC is recalling 4,347 syringes of fentanyl citrate injection, 50 mcg per mL, preservative free, 1 mL total volume in a syringe, for IV use. The product is identified by product code 2R3153. The recall covers lots with expiration dates between 07/15/15 and 10/12/15, including lot numbers 15100052M, 15103048M, 15104052M, 15118032M, 15127009M, 15127068M, 15134039M, 15135009M, 15135054M, 15140070M, 15147039M, 15148065M, 151900145M, and 151930043M.

The recall was initiated because of confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes. Additionally, stability data does not support the stated expiry dates for these products. The FDA has classified this recall as Class II.

The affected products were distributed nationwide. Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be stopped from use and returned to the distributor or manufacturer according to recall instructions.

The recalled product

Product
fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Opioid
Hazard
Affected units
4,347

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 (15)

  • Lot Numbers: 15100052M
  • 15103048M
  • 15104052M
  • 15118032M
  • 15127009M
  • 15127068M
  • 15134039M
  • 15135009M
  • 15135054M
  • 15140070M
  • 15147039M
  • 15148065M
  • 151900145M
  • 151930043M
  • Exp between 07/15/15-10/12/15

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 →

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