D-0816-2026 Class II Ongoing
FDA drug recall D-0816-2026 was initiated by Baxter Healthcare Corporation on August 6, 2026 and is designated Class II. Reason for recall: CGMP Deviations The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- September 9, 2026
- Initiation Date
- August 6, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-9549-50.
Reason for Recall
CGMP Deviations
Distribution Pattern
US Nationwide; Puerto Rico; and Chile.
Code Information
Lot # NC193689, Exp Date: 10/16/2027.