Clindamycin Phosphate in 0.9% Sodium Chloride Injection recall (Baxter Healthcare Corporation)
DrugClass IIOngoing
Summary: Baxter Healthcare Corporation is recalling 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: CGMP Deviations.
What is being recalled
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.
Why
CGMP Deviations
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide; Puerto Rico; and Chile. (states named: Puerto Rico)
How to tell if yours is affected
Lot # NC193689, Exp Date: 10/16/2027.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0816-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 6, 2026 |
| Reported | September 9, 2026 |
| Company | Baxter Healthcare Corporation |
| Company location | Deerfield, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | N/A |
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