Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter H…
Baxter Healthcare Corporation · CGMP Deviations
- Status
- Ongoing
- City
- Deerfield
- State
- IL
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99500
- Recalling firm
- Baxter Healthcare Corporation
- Address 1
- 1 Baxter Pkwy
- Address 2
- N/A
- Postal code
- 60015-4625
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- US Nationwide; Puerto Rico; and Chile.
- Recall number
- D-0811-2026
- Product quantity
- N/A
- Reason for recall
- CGMP Deviations
- Recall initiation date
- 20260806
- Center classification date
- 20260828
- Report date
- 20260909
- Code info
- Lot # NC193672, NC193795, Exp Date: 04/30/2028; Lot # NC194198, Exp Date: 05/31/2028.
- Product description
Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60012 USA, NDC 0338-9640-12.
- Harmonized identifiers (openFDA)
- Application number
- NDA217569
- Brand name
- VASOPRESSIN IN 0.9% SODIUM CHLORIDE
- Generic name
- VASOPRESSIN IN 0.9% SODIUM CHLORIDE
- Manufacturer name
- Baxter Healthcare Corporation
- Product NDC
- 0338-9640, 0338-9647
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- VASOPRESSIN
- RxCUI
- 2399907, 2591428
- SPL ID
- e5fb5b63-6f2e-4ebe-9a55-147a793e95dd
- SPL set ID
- b5b2c367-6b7e-40be-a296-c4632f3e783f
- Package NDC
- 0338-9640-12, 0338-9647-12
- Is original packager
- true
- Nui
- M0022562, N0000009908, N0000175360
- Pharm class cs
- Vasopressins [CS]
- Pharm class pe
- Vasoconstriction [PE], Decreased Diuresis [PE]
- UNII
- Y4907O6MFD