The Recall Desk
HighFDA (Drugs)·D-1268-2022·Announced 2022-07-27

Morphine Sulfate Injection Recalled Due to Sterility Assurance Concerns

Nephron Sterile Compounding Center LLC is recalling morphine sulfate injection syringes due to lack of assurance of sterility. The recall affects 4,620 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 an FDA Class II recall involving a potential sterility defect in an injectable medication, which poses a high risk of harm. No illnesses or hospitalizations are reported in the source text, so the hazard remains theoretical, capping the score at 3 per the rubric.

Plain-English summary

Morphine Sulfate Injection, USP (1 mg/mL), manufactured by Nephron Sterile Compounding Center LLC, is being recalled due to lack of assurance of sterility. The recall affects 4,620 pre-filled syringes (lot MS2010A, expiration 8/26/2022) that were distributed nationwide.

Non-sterile injectable products can pose serious health risks. Consumers should not use syringes from this lot and should consult their healthcare provider or pharmacist for guidance on obtaining replacement medication.

The recalled product

Product
Morphine Sulfate Injection, USP, 1 mg/mL syringe, packaged in 5 x 1 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: 69374-979-01
Manufacturer
Nephron Sterile Compounding Center LLC
Category
Drug — Injectable
Hazard
  • sterility-failure

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: MS2010A
  • Exp. 8/26/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category