The Recall Desk
HighFDA (Drugs)·D-1331-2022·Announced 2022-08-17

FentaNYL Citrate IV solution recalled due to sterility assurance concerns

SterRx is recalling FentaNYL Citrate intravenous bags (10 mcg/mL) due to lack of assurance of sterility. The recalled lot (CHI, expiring December 2022) was distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving lack of sterility assurance in an intravenous opioid medication, representing a high-risk contamination scenario. No illnesses or injuries have been reported, making this a theoretical risk-of-harm situation consistent with the High severity classification.

Plain-English summary

SterRx, LLC is recalling FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) intravenous bags due to a lack of assurance of sterility. The recalled lot is CHI with an expiration date of December 2022; 720 bags were distributed nationwide in the United States.

Patients and healthcare providers who may have received the affected product should contact SterRx, their dispensing pharmacy, or their healthcare provider for guidance. This is a prescription-only product administered intravenously.

The recalled product

Product
FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.
Manufacturer
SterRx, LLC
Category
Drug — Intravenous / Opioid
Hazard
  • lack-of-sterility

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 (3)

  • Lot #: CHI
  • Exp. Date Dec 22
  • 2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category