Baxter Nexterone amiodarone injection recalled for CGMP manufacturing deviations
Baxter Healthcare has recalled multiple lots of Nexterone (amiodarone HCI) injection due to deviations from good manufacturing practices (CGMP) during production. The affected lots were distributed nationwide, Puerto Rico, and Chile. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Baxter recalls
What to do
- Check your facility's inventory against the affected lot numbers and expiration dates listed in the recall notice.
- Do not use affected lots; quarantine and return them to your supplier or Baxter Healthcare.
- Contact Baxter Healthcare or your distributor for replacement stock if needed.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20.
- Sold in
- Nationwide
- Made for
- Adults
This recall covers 17 products — see all of them.
Details
- Units affected
- N/A
- Illnesses reported
- None reported
- Manufactured in
- 1 Baxter Pkwy, N/A, Deerfield, IL, United States
- Classification
- Class II
- Recall number
- D-0814-2026
In the FDA's words
- Description
- Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20. CGMP Deviations Lot # NC177832, Exp Date: 12/31/2026; Lot # NC185417, NC185455, Exp Date: 08/31/2027; Lot # NC188593, Exp Date: 11/30/2027; Lot # NC188647, NC188685, NC188807, NC188838, NC188920, Exp Date: 12/31/2027; Lot # NC193603, NC193726, NC193788, NC193863, NC193900, Exp Date: 04/30/2028; Lot # NC194082, NC194112, NC194143, NC195157, Exp Date: 05/31/2028. Distribution: US Nationwide; Puerto Rico; and Chile. Affected quantity: N/A
- Hazard
- CGMP Deviations
17 products in this recall
Baxter IV drug bags recalled for manufacturing quality issues
Baxter is recalling 17 intravenous (IV) drug products for manufacturing quality problems, called CGMP deviations, which are lapses in the required production standards. The products include vancomycin, daptomycin, clindamycin, famotidine, dexmedetomidine, vasopressin, pantoprazole, insulin, nicardipine, and amiodarone, plus the brand names Myxredlin, CARDENE IV, and Nexterone. They were distributed nationwide, in Puerto Rico, and in Chile, and no injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Health…D-0805-2026 · N/A
- MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, ND…D-0806-2026 · N/A
- Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile N…D-0807-2026 · N/A
- Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare…D-0808-2026 · N/A
- Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Ba…D-0809-2026 · N/A
- Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Health…D-0810-2026 · N/A
- 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 Corporat…D-0811-2026 · N/A
- Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter…D-0812-2026 · N/A
- 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 Mark…D-0813-2026 · N/A
- Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Health… (this page)D-0814-2026 · N/A
- Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare…D-0815-2026 · N/A
- Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxt…D-0816-2026 · N/A
- Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Bax…D-0817-2026 · N/A
- Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Bax…D-0818-2026 · N/A
- Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporat…D-0819-2026 · N/A
- Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare…D-0820-2026 · N/A
- Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogeni…D-0821-2026 · N/A
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