CLASS II ONGOING Drug recall · Reported 24 Jan 2024 · FDA Enforcement Report
Vasostrict (vasopressin in 5% Dextrose) Injection per mL) recalled
Par Sterile Products is recalling Vasostrict (vasopressin in 5% Dextrose) Injection per mL) x Dose Vials per, Ready to Use, distributed nationwide in the US. The recall was initiated on 11 Jan 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0232-2024
- FDA event ID
- 93805
- Recalling firm
- Par Sterile Products, Rochester, MI
- Brand
- Vasostrict
- Manufacturer
- Par Health USA, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Jan 2024
- FDA classified
- 16 Jan 2024
- Reported
- 24 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 11 Jan 2024 | Recall initiated by company | |
| 16 Jan 2024 | Classified by FDA | +5 days |
| 24 Jan 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-237-10
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Which lots are affected?
Lot # 66702; Exp. 02/2025
Where was it sold?
Nationwide USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Par Sterile Products
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Treprostinil Injection, 20 mg/ (1 mg/mL) recalled | Par Sterile Products | Particulate Matter | Nationwide |
| Drug | CLASS II | Buprenorphine HCl, Injection, 0.3mg/mL recalled by PAR Sterile ProductsBuprenorphine Hydrochloride | PAR Sterile Products | Packaging Defects | Nationwide |
| Drug | CLASS II | Buprenorphine HCI Injection, 0.3 mg/mL Single Dose Vial recalledBuprenorphine Hydrochloride | PAR Sterile Products | Particulate Matter | Nationwide |
Other Vasopressin recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vasopressin, in 0.9% Sodium Chloride Injection per/mL) recalledVasopressin In 0.9% Sodium Chloride | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Vasopressin, in 0.9% Sodium Chloride Injection per/mL) recalledVasopressin In 0.9% Sodium Chloride | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Vasopressin Injection, USP per mL) Multiple-Dose Vial recalledVasopressin | American Regent | Potency & Assay | Nationwide |
| Drug | CLASS II | Vasopressin in 0.9% Sodium Chloride Sterile Syringe recalled | IntegraDose Compounding Services | Potency & Assay | MN |