Drug product
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
D-0987-2022
Product summary
- Event
- Event 90257
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1992 vials
- Official record key
drug-enforcement:D-0987-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 02RP1507A, exp. date 30-Jun-22; 02RP1512A, exp. date 30-Sep-22; 02RP1514A, exp. date 31-Nov-22; 02RP1515A, exp. date 31-Dec-22
Distribution pattern: Product was distributed to medical facilities and a physician's office Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility