Drug & medication recalls Moderate risk

Safecor Health, LLC recalls Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safec…

Recall date
February 17, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0254-2025
FDA classification
Class II
Brand / firm
Safecor Health, LLC
Sold / distributed
Nationwide in the USA

Why it was recalled

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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