Morphine Sulfate Oral Syringes Recalled for Defective Delivery System Leakage
Safecor Health is recalling Morphine Sulfate 5 mg oral syringes nationwide due to leakage in the delivery system following repackaging. No illnesses have been reported.
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 drug recall involving a high-risk product (morphine opioid). The defective delivery system creates a real risk of harm through potential leakage and dosing errors, but no illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3.
Plain-English summary
Safecor Health, LLC is recalling Morphine Sulfate 5 mg per 0.25 mL Oral Syringes distributed nationwide in the United States. The product was manufactured by Hikma and packaged by Safecor Health, LLC. Approximately 12,390 oral syringes are involved in this recall.
The recall was initiated due to leakage observed after the oral solution was repackaged into unit-dose syringes. The defective delivery system could potentially affect proper medication administration.
Patients and healthcare providers in possession of these syringes should discontinue use and consult with their pharmacy or healthcare provider regarding this recall.
The recalled product
- Product
- Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750.
- Manufacturer
- Safecor Health, LLC
- Category
- Drug — Opioid Oral Solution
- Hazard
- leakage
- delivery-system-defect
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 (15)
- Lot #s: a) 24220672
- Exp 02/19/2025
- 24280145
- Exp 03/18/2025
- 24240711
- Exp 03/19/2025
- b) 24180729
- Exp 01/23/2025
- 25030427
- Exp 07/17/2025
- c) 24360865
- 24360864
- Exp 03/31/2025
- 24480235
- Exp 06/21/2025.
Distribution
Distributed nationwide across the United States.
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