Class II · Moderate risk
Vasopressin
CGMP Deviations
Vasopressin Injection
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.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
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
Affected NDC
0517-1030-01
Compare with the code on your package — it is the most precise check available.
Drug: Vasopressin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Vasopressin NDC 00517-1030 |
20 [USP'U]/mL | Injection, Solution Intravenous |
American Regent, Inc. | Rx |
- 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 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Vasopressin recalls
See all
Class II · Moderate risk
Vasopressin
CGMP Deviations
Class II · Moderate risk
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride
Subpotent Drug
Class II · Moderate risk
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection
Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Class II · Moderate risk
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride
Subpotent Drug
Other recalls by American Regent, Inc.
All 2024 recalls
Class I · High risk
Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Class II · Moderate risk
niCARdipine Hydrochloride Injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Class II · Moderate risk
Tralement (trace elements injection 4*, USP)
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Class I · High risk
Papaverine HCl Injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
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