← FDA ENFORCEMENT
D-0253-2025Class 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
3465 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

Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784.

Code / lot info

Lot #s: a) 24210274, Exp 01/31/2025; 24401700, Exp 04/25/2025; b) 24251067, Exp 03/25/2025; 24421733, Exp 06/03/2025; c) 24261384, Exp 03/24/2025; 24370127, Exp 04/28/2025.

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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.