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.
Reported: March 12, 2025 Initiated: February 17, 2025 #D-0253-2025
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.
Reason for Recall
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Details
- Recalling Firm
- Safecor Health, LLC
- Units Affected
- 3465 Oral Syringes
- Distribution
- Nationwide in the USA
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Safecor Health, LLC. Units affected: 3465 Oral Syringes.
Why was this product recalled? ▼
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 12, 2025. Severity: Moderate. Recall number: D-0253-2025.
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