Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Re…
American Regent, Inc. · Subpotent product in addition to having out-of-specification results for impurities.
- Status
- Terminated
- City
- New Albany
- State
- OH
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 94619
- Recalling firm
- American Regent, Inc.
- Address 1
- 6610 New Albany Rd E
- Postal code
- 43054-8730
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- USA Nationwide
- Recall number
- D-0507-2024
- Product quantity
- 2,352 vials
- Reason for recall
- Subpotent product in addition to having out-of-specification results for impurities.
- Recall initiation date
- 20240513
- Center classification date
- 20240521
- Termination date
- 20251222
- Report date
- 20240529
- Code info
- Lot #: 23061L1C0, Exp 1/31/2025
- 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
- Harmonized identifiers (openFDA)
- Application number
- NDA212593
- Brand name
- VASOPRESSIN
- Generic name
- VASOPRESSIN
- Manufacturer name
- American Regent, Inc.
- Product NDC
- 0517-1020, 0517-1030
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- VASOPRESSIN
- RxCUI
- 313578, 2103182
- SPL ID
- 36148e09-1c3c-4878-a194-8e10291972ff
- SPL set ID
- 0ab267f4-9ec9-44fd-8521-f975074667d9
- Package NDC
- 0517-1020-01, 0517-1020-25, 0517-1030-01
- Is original packager
- true
- Upc
- 0305171030017
- Nui
- M0022562, N0000009908, N0000175360
- Pharm class cs
- Vasopressins [CS]
- Pharm class pe
- Vasoconstriction [PE], Decreased Diuresis [PE]
- UNII
- Y4907O6MFD