Baxter Clindamycin Injection recalled for CGMP manufacturing deviations
Baxter Healthcare Corporation is recalling specific lots of Clindamycin Injection USP in 5% Dextrose due to deviations from current Good Manufacturing Practice (CGMP) standards during production. The affected lots are NC193764 (expiration 10/18/2027) and NC195232 (expiration 11/25/2027), distributed nationwide in the US, Puerto Rico, and Chile.
From the FDA notice · Read the official notice ↗ · All Baxter recalls
What to do
- Check your pharmacy or hospital records for Clindamycin Injection with lot numbers NC193764 or NC195232.
- Do not use affected lots; contact your pharmacy or healthcare provider for guidance on safe alternatives.
- Report any adverse effects to FDA MedWatch at 1-888-SAFEMED or online at fda.gov/medwatch.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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 Corporation, Deerfield, IL 60015 USA, NDC 0338-3612-50.
- 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-0808-2026
In the FDA's words
- Description
- 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 Corporation, Deerfield, IL 60015 USA, NDC 0338-3612-50. CGMP Deviations Lot # NC193764, Exp Date: 10/18/2027; Lot # NC195232, Exp Date: 11/25/2027. 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… (this page)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…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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