The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1255-2022·Announced 2022-07-27

HYDROmorphone Injection Recalled Due to Lack of Sterility Assurance

Nephron Sterile Compounding Center recalled 22,805 pre-filled syringes of HYDROmorphone HCl Injection due to lack of sterility assurance. Six lot numbers were distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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 of injectable medication where sterility cannot be assured. No illnesses or injuries have been reported. The hazard is theoretical contamination risk rather than confirmed harm. Per the rubric, a risk-of-harm product without reported injury scores 3 (High).

Plain-English summary

Nephron Sterile Compounding Center LLC has recalled HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) pre-filled syringes. The recall affects approximately 22,805 syringes across six lot numbers: HH2002A (expires 7/7/2022), HH2004A (expires 8/28/2022), HH2005A (expires 8/11/2022), HH2007A (expires 9/2/2022), HH2009A (expires 9/10/2022), and HH2011A (expires 10/17/2022).

The manufacturer cannot assure that the affected product is sterile. Use of non-sterile injectable medication poses a risk of microbial contamination and potential infection in patients receiving injections.

The recalled product was distributed nationwide in the United States. Product from the affected lot numbers should not be administered to patients.

The recalled product

Product
HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-529-50
Manufacturer
Nephron Sterile Compounding Center LLC
Category
Drug — Injectable Opioid
Hazard
Affected units
22,805

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 (12)

  • Lots: HH2002A
  • Exp. 7/7/2022
  • HH2004A
  • Exp. 8/28/2022
  • HH2005A
  • Exp. 8/11/2022
  • HH2007A
  • Exp. 9/2/2022
  • HH2009A
  • Exp. 9/10/2022
  • HH2011A
  • Exp. 10/17/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 37 recalled by Nephron Sterile Compounding Center 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 37 products in this recall →

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