Recalls / Class II
Class IID-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.
- Affected lot / code 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.
Why it was recalled
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Recalling firm
- Firm
- Safecor Health, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4060 Business Park Dr Ste B, Columbus, Ohio 43204-5047
Distribution
- Quantity
- 3465 Oral Syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-02-17
- FDA classified
- 2025-03-05
- Posted by FDA
- 2025-03-12
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0253-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.