← FDA ENFORCEMENT
D-0254-2025Class II

Safecor Health, LLC

Recalling firm
Safecor Health, LLC
Product type
Drug
Status
Ongoing
Report date
2025-03-12
Distribution
Nationwide in the USA
Firm state
OH
Product quantity
12390 Oral Syringes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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

Product description

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.

Code / lot info

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.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.