The Recall Desk

Manufacturer

Par Sterile Products LLC

4 recalls in our database name Par Sterile Products LLC as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
1
Most recent
2024-04-03

Of the 4 recalls from Par Sterile Products LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (25%) 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.

1–4 of 4

  • SevereFDA (Drugs)·D-0429-2024·2024-04-03

    Treprostinil Injection recalled nationwide due to particulate matter contamination

    Par Pharmaceutical is recalling Treprostinil Injection nationwide due to the presence of particulate matter. This FDA Class I recall affects 466 vials of lot 57014 distributed throughout the United States.

    Product
    Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0232-2024·2024-01-24

    FDA Recalls Vasostrict Injection for Exceeding Potency Specifications

    Par Sterile Products recalled Vasostrict (vasopressin) injection because stability testing showed the drug exceeded its upper potency specification limit. The recall involves 1,721 cartons distributed nationwide.

    Product
    VASOSTRICT — VASOSTRICT (VASOPRESSIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0087-2024·2023-11-15

    Buprenorphine HCl Injection Recalled for Crystallization Defect

    Buprenorphine HCl injection is being recalled nationwide due to white crystalline agglomeration found in stored product samples during routine inspection.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide