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Recall Observatory FDA recall evidence

Drug 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.

D-0254-2025

February 17, 2025

Class II

Product summary

Firm
Safecor Health, LLC
Event
Event 96308
Status
Ongoing
Classification
Class II
Quantity
12390 Oral Syringes
Official record key
drug-enforcement:D-0254-2025

Official wording

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

Code information: 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 pattern: Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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