FDAHealthFebruary 17, 2025
Safecor Health, LLC — 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)
⚠️ Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 17, 2025
Nationwide in the USA
What's affected?
- 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.
- Brand
- Safecor Health, LLC
- Lot code
- a)
Additional details
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.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 12390 Oral Syringes.
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