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.
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 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
- Affected units
- 4,620
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.
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.
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