D-0987-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 15, 2022
- Initiation Date
- May 24, 2022
- Termination Date
- June 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1992 vials
Product 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
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Product was distributed to medical facilities and a physician's office Nationwide in the USA.
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