FDA Drug recall D-0987-2022
B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Rib…
- FDA Drug
- Class II
- terminated
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class II recall of B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Rib… by Us Specialty Formulations, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0987-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-05-24 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Us Specialty Formulations |
| Distribution | US |
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
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0987-2022%22
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