D-0809-2026 Class II Ongoing
FDA drug recall D-0809-2026 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
Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-5197-41.
Reason for Recall
CGMP Deviations
Distribution Pattern
US Nationwide; Puerto Rico; and Chile.
Code Information
Lot # NC188586, Exp Date: 02/28/2027; Lot # NC188913, Exp Date: 3/9/2027.