The Recall Desk

Manufacturer

US Specialty Formulations LLC

2 recalls in our database name US Specialty Formulations LLC as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2022-06-15

Of the 2 recalls from US Specialty Formulations LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Drugs)·D-0986-2022·2022-06-15

    FDA Recalls Ethanol Injection Vials Due to Sterility Concerns

    US Specialty Formulations is recalling 781 vials of Ethanol for Injection 95% due to lack of assurance of sterility. The product was distributed nationwide to medical facilities and physician offices.

    Product
    Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0987-2022·2022-06-15

    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.

    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
    Category
    Drug
    Distribution
    Distributed nationwide