CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Man…
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-0813-2026
- Product quantity
- N/A
- Reason for recall
- CGMP Deviations
- Recall initiation date
- 20260806
- Center classification date
- 20260828
- Report date
- 20260909
- Code info
- Lot # NC177818, Exp Date: 12/31/2026; Lot # NC188869, Exp Date: 12/31/2027.
- Product description
CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-016-10.
- Harmonized identifiers (openFDA)
- Application number
- NDA019734
- Brand name
- CARDENE IV
- Generic name
- NICARDIPINE HYDROCHLORIDE
- Manufacturer name
- Baxter Healthcare Corporation
- Product NDC
- 43066-009, 43066-016
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- NICARDIPINE HYDROCHLORIDE
- RxCUI
- 858599, 858601, 858603, 858605
- SPL ID
- 29b8dd22-cb60-44ee-b715-3f185a1118a7
- SPL set ID
- f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e
- Package NDC
- 43066-016-10, 43066-009-10
- Is original packager
- true
- UNII
- K5BC5011K3