Product Safety Recalls

Product Recall Tracker

Recall D-1262-2022

Description: Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04

Recall D-1262-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1262-2022
Event ID90512
DistributionNationwide in the USA
Quantity184,370 syringes
Recall ReasonLack of Assurance of Sterility
Drug ClassificationClass II
Drug Code Info20220727
Recall Initiation Date20220630
Report Date20220727
Classification Date20220718
Address4500 12th Street Ext
West Columbia, SC 29172-3025
United States
Recalling FirmNephron Sterile Compounding Center LLC
Initial Notification Letter
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