Product Safety Recalls

Product Recall Tracker

Recall D-0966-2022

Description: Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10

Recall D-0966-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0966-2022
Event ID90211
DistributionNationwide in the USA
Quantity76860 syringes
Recall ReasonLack of Assurance of Sterility
Drug ClassificationClass II
Drug Code Info20220608
Recall Initiation Date20220518
Report Date20220608
Classification Date20220527
Address4500 12th Street Ext
West Columbia, SC 29172-3025
United States
Recalling FirmNephron Sterile Compounding Center LLC
Initial Notification Letter
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