Agency classClass IIOur severity:High FDA (Drugs)·D-0987-2022·Announced 2022-06-15

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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…
Manufacturer: US Specialty Formulations LLC
Category: Drug — Injectable / Nutritional Supplement
Hazard: lack-of-sterility
potential-contamination
Affected units: 1,992

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.

Part of a larger recall action

This product is one of 2 recalled by US Specialty Formulations LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · US Specialty Formulations LLC

See all →

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