The Recall Desk
HighFDA (Drugs)·D-0958-2022·Announced 2022-06-08

Injectable Hydromorphone Recalled for Lack of Sterility Assurance

Nephron Sterile Compounding Center is recalling Hydromorphone HCl Injection due to lack of assurance of sterility. The recall affects 6,210 pre-filled syringes 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: FDA Class II recall of injectable drug with potential sterility assurance failure. Non-sterile injectables pose serious risk of contamination and infection, meeting the criterion for high-risk products where injury has not been reported.

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling Hydromorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) pre-filled syringes due to lack of assurance of sterility. This is an FDA Class II recall.

The recalled product consists of 6,210 pre-filled syringes in cartons (lot HH2008A, expiration 9/5/2022, NDC 69374-529-30) that were distributed nationwide in the USA. The compounding facility is located at 4500 12th St. Extension, West Columbia, SC 29172.

Patients and healthcare providers with this product should not use it and should consult their healthcare provider for guidance on management of their condition.

The recalled product

Product
Hydromorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL), 30 mL Pre-Filled Syringe, 5 x 30 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-529-30
Manufacturer
Nephron Sterile Compounding Center LLC
Category
Drug — Injectable / Opioid
Hazard
Affected units
6,210

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: HH2008A
  • Exp. 9/5/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 20 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 20 products in this recall →

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