Product Safety Recalls

Product Recall Tracker

Recall D-0986-2022

Description: Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229

Recall D-0986-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0986-2022
Event ID90257
DistributionProduct was distributed to medical facilities and a physician's office Nationwide in the USA.
Quantity781 vials
Recall ReasonLack of Assurance of Sterility
Drug ClassificationClass II
Drug Code Info20220615
Recall Initiation Date20220524
Report Date20220615
Classification Date20220606
Address1401 S Albert St
Allentown, PA 18103-4141
United States
Recalling FirmUS Specialty Formulations LLC
Initial Notification Letter
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