FDA recall D-0253-2025

Product

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.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2025-02-17

Report date

2025-03-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0253-2025