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, U

FDA recall notice · announced June 15, 2022 · Us Specialty Formulations

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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 for recall

Lack of Assurance of Sterility

Notes

Distribution: Product was distributed to medical facilities and a physician's office Nationwide in the USA.
Lot/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
Quantity: 1992 vials
Status: Terminated
Products in this recall event:
- Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229 (D-0986-2022)
- 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 Via (D-0987-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.