Recall D-0987-2022
Description: B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Vials per carton, US Specialty Formulations, LLC, 116 Research Drive, Bethlehem, PA 18015, P/N: 234-15523
Recall D-0987-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0987-2022 |
Event ID | 90257 |
Distribution | Product was distributed to medical facilities and a physician's office Nationwide in the USA. |
Quantity | 1992 vials |
Recall Reason | Lack of Assurance of Sterility |
Drug Classification | Class II |
Drug Code Info | 20220615 |
Recall Initiation Date | 20220524 |
Report Date | 20220615 |
Classification Date | 20220606 |
Address | 1401 S Albert St Allentown, PA 18103-4141 United States |
Recalling Firm | US Specialty Formulations LLC |
Initial Notification | Letter |
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