B-Complex plus Chromic Chloride injection recall for lack of sterility assurance
US Specialty Formulations is recalling B-Complex plus Chromic Chloride injectable vials due to lack of assurance of sterility. The product was distributed to medical facilities and physician offices nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable product due to lack of assurance of sterility. No illnesses or injuries have been reported. Per the severity rubric, recalls of risk-of-harm products where injury has not yet been reported receive a High (3) severity score.
Plain-English summary
US Specialty Formulations LLC is recalling specific lot numbers of B-Complex + Chromic Chloride injectable vials due to lack of assurance of sterility. This product is a multi-nutrient injection supplied in 30 mL multi-dose vials with the following composition: choline chloride 3%, inositol 3%, pyridoxine HCl 2%, niacinamide 2%, thiamine HCl 2%, chlorobutanol 0.5%, riboflavin 0.05%, and chromic chloride 0.003%.
The affected lot numbers are 02RP1507A (expiration date 30-Jun-22), 02RP1512A (expiration date 30-Sep-22), 02RP1514A (expiration date 31-Nov-22), and 02RP1515A (expiration date 31-Dec-22). A total of 1,992 vials were involved in this recall. The product was distributed to medical facilities and a physician's office throughout the United States.
The manufacturer initiated this recall due to lack of assurance of sterility, which is a critical quality attribute for injectable products. Healthcare providers who received this product and patients who may have received injections should be aware of this recall.
The recalled product
- 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
- Manufacturer
- US Specialty Formulations LLC
- Hazard
- lack-of-sterility
- potential-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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
Distributed nationwide across the United States.
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