Recalls / Class II
Class IID-0507-2024
Product
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
- Brand name
- Vasopressin
- Generic name
- Vasopressin
- Active ingredient
- Vasopressin
- Route
- Intravenous
- NDCs
- 0517-1020, 0517-1030
- FDA application
- NDA212593
- Affected lot / code info
- Lot #: 23061L1C0, Exp 1/31/2025
Why it was recalled
Subpotent product in addition to having out-of-specification results for impurities.
Recalling firm
- Firm
- American Regent, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6610 New Albany Rd E, New Albany, Ohio 43054-8730
Distribution
- Quantity
- 2,352 vials
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2024-05-13
- FDA classified
- 2024-05-21
- Posted by FDA
- 2024-05-29
- Terminated
- 2025-12-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0507-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.