Class II · Moderate risk Ongoing
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900…
Reason Subpotent Drug
Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent product in addition to having out-of-specification results for impurities.
What was recalled
Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01
- Recalling firm
- American Regent, Inc.
- NDC code
- 0517-1030-01
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0507-2024
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Vasopressin recalls
See all
Class II · Moderate risk Ongoing
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only…
Reason Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Class II · Moderate risk Ongoing
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per…
Reason Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Class II · Moderate risk Terminated
vasopressin 50 units added to 0.9% sodium chloride 50 mL*, 1 unit/mL*, 50 mL in 100 mL Partial Additive Bag, Rx only, Central…
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
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