The Recall Desk
HighFDA (Drugs)·D-1265-2022·Announced 2022-07-27

Morphine Sulfate Injection Recalled for Lack of Sterility Assurance

Nephron Sterile Compounding Center is recalling Morphine Sulfate Injection due to lack of assurance of sterility. The recall affects 5,495 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: This is a Class II FDA recall for a sterile injectable drug with lack of assurance of sterility, which poses a potential contamination risk. No illnesses or injuries have been reported in the source material.

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling Morphine Sulfate Injection, USP, 50 mg/50 mL in pre-filled syringes. The recall involves 5,495 syringes packaged 5 per carton, with 6 cartons per case, distributed nationwide.

The affected lot numbers are MS2002A (expires 7/2/2022), MS2003A (7/30/2022), MS2005A (7/31/2022), MS2008A (8/23/2022), MS2013A (9/9/2022), MS2015A (9/26/2022), and MS2019A (10/14/2022).

The recall was initiated due to lack of assurance of sterility. This is classified as a Class II FDA recall.

The recalled product

Product
Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-50
Manufacturer
Nephron Sterile Compounding Center LLC
Category
Drug — Injectable Opioid
Hazard
Affected units
5,495

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 (14)

  • Lots: MS2002A
  • Exp. 7/2/2022
  • MS2003A
  • Exp. 7/30/2022
  • MS2005A
  • Exp. 7/31/2022
  • MS2008A
  • Exp. 8/23/2022
  • MS2013A
  • Exp. 9/9/2022
  • MS2015A
  • Exp. 9/26/2022
  • MS2019A
  • Exp. 10/14/2022

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 →

Related recalls

Same manufacturer · Nephron Sterile Compounding Center LLC

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Same hazard · lack of sterility

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