Product Safety Recalls

Product Recall Tracker

Recall D-1347-2022

Description: PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34

Recall D-1347-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1347-2022
Event ID90718
DistributionNationwide in the USA
Quantity33,870 vials
Recall ReasonCGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Drug ClassificationClass II
Drug Code Info20220824
Recall Initiation Date20220810
Report Date20220824
Classification Date20220816
Address4500 12th Street Ext
West Columbia, SC 29172-3025
United States
Recalling FirmNephron Sterile Compounding Center LLC
Initial Notification Letter
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