# FDA recall D-0987-2022

> **US Specialty Formulations LLC** · Class II · drug recall initiated 2022-05-24.

## 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

## Distribution

Product was distributed to medical facilities and a physician's office Nationwide in the USA.

## Key facts

- **Recall number:** D-0987-2022
- **Recalling firm:** US Specialty Formulations LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-05-24
- **Report date:** 2022-06-15
- **Termination date:** 2024-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allentown, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0987-2022

## Citation

> AI Analytics. FDA recall D-0987-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0987-2022. Source: US FDA. Licensed CC0.

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