Why it was recalled
Subpotent product in addition to having out-of-specification results for impurities.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 23061L1C0, Exp 1/31/2025
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0507-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 13, 2024
- FDA report date
- May 29, 2024
- Quantity
- 2,352 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Regent, Inc.
Original FDA data
Every field from FDA enforcement report D-0507-2024, exactly as published.
Show all FDA fields
- City
- New Albany
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 94619
- Address
- 6610 New Albany Rd E
- Code information
- Lot #: 23061L1C0, Exp 1/31/2025
- Postal code
- 43054-8730
- Report date
- May 29, 2024
- Product type
- Drugs
- Recall number
- D-0507-2024
- Classification
- Class II
- Recalling firm
- American Regent, Inc.
- Product quantity
- 2,352 vials
- Termination date
- Dec 22, 2025
- Reason for recall
- Subpotent product in addition to having out-of-specification results for impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- May 13, 2024
- Initial firm notification
- Letter
- Center classification date
- May 21, 2024