The Recall Desk
HighFDA (Drugs)·D-1266-2022·Announced 2022-07-27

Morphine Sulfate Injection Recalled Due to Lack of Sterility Assurance

Nephron Sterile Compounding Center LLC is recalling Morphine Sulfate Injection due to lack of assurance of sterility. The recall affects 8,985 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: The recall involves a Class II drug with a lack of sterility assurance on injectable medication. No illnesses or injuries have been reported. This falls under 'risk-of-harm products where injury has not yet been reported,' per the severity rubric.

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL), packaged in pre-filled syringes. The recall was initiated due to lack of assurance of sterility.

The recall affects approximately 8,985 syringes distributed nationwide in the USA across six lot numbers: MS2004A (expiration 7/30/2022), MS2007A (expiration 8/23/2022), MS2012A (expiration 9/6/2022), MS2014A (expiration 9/10/2022), MS2016A (expiration 9/29/2022), and MS2018A (expiration 10/12/2022). The product NDC is 69374-979-30. Morphine Sulfate Injection is a prescription-only medication.

Patients and healthcare providers who received affected lots should discontinue use immediately and consult with their pharmacy or healthcare provider. Do not use the medication. For product disposal or additional information, contact Nephron Sterile Compounding Center LLC at 4500 12th St. Extension, West Columbia, SC 29172, or refer to FDA recall number D-1266-2022.

The recalled product

Product
Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 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: 69374-979-30
Manufacturer
Nephron Sterile Compounding Center LLC
Category
Drug — Injectable Opioid
Hazard
  • sterility-assurance
  • contamination

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: MS2004A
  • Exp. 7/30/2022
  • MS2007A
  • Exp. 8/23/2022
  • MS2012A
  • Exp. 9/6/2022
  • MS2014A
  • Exp. 9/10/2022
  • MS2016A
  • Exp. 9/29/2022
  • MS2018A
  • Exp. 10/12/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category