FDA-Drug2025-03-12Class II
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.
Safecor Health, LLC
Hazard
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Sold states
Nationwide in the USA
Affected count
3465 Oral Syringes
Manufactured in
4060 Business Park Dr Ste B, Columbus, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0253-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief