Agency classClass IIOur severity:High FDA (Drugs)·D-1267-2022·Announced 2022-07-27

Morphine Sulfate Injection Recalled for Lack of Sterility Assurance

Nephron Sterile Compounding Center is recalling Morphine Sulfate Injection syringes distributed nationwide due to lack of assurance of sterility. Approximately 43,385 syringes are affected.

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 FDA Class II recall involves an injectable medication where sterility assurance is critical. Although sterility failures in injectables pose a serious potential health risk, no illnesses or adverse events have been reported, placing this in the risk-of-harm category without documented injury.

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) pre-filled syringes distributed nationwide in the United States. Approximately 43,385 syringes are affected by this recall.

The recall was initiated due to lack of assurance of sterility. The affected lot numbers and expiration dates are: MS2001A (Exp. 7/2/2022), MS2006A (Exp. 8/9/2022), MS2009A (Exp. 8/25/2022), MS2011A (Exp. 9/3/2022), and MS2017A (Exp. 10/2/2022). This is a prescription-only product from Nephron's 503B outsourcing facility.

No illnesses or adverse events have been reported in association with this recall. Healthcare providers and patients should contact their healthcare provider or pharmacist if they have questions about medication from the affected lots.

The recalled product

Product: Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x 2 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: 69374-979-02
Manufacturer: Nephron Sterile Compounding Center LLC
Category: Drug — Pre-filled Syringe
Hazard: sterility-failure
Affected units: 43,385

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 (10)

Lots: MS2001A
Exp. 7/2/2022
MS2006A
Exp. 8/9/2022
MS2009A
Exp. 8/25/2022
MS2011A
Exp. 9/3/2022
MS2017A
Exp. 10/2/2022

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 →

Same manufacturer · Nephron Sterile Compounding Center LLC

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Same hazard · sterility failure