Baxter Clindamycin Injection Recall Over CGMP Deviations
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Baxter Healthcare Corporation is recalling specific lots of Clindamycin Injection USP in 5% Dextrose due to CGMP deviations.
Reading this FDA recall beyond the headline
This notice was issued by FDA on September 14, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "CGMP Deviations", distributed us nationwide; puerto rico; and chile.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
It is tempting to skim, check personal relevance, and move on. The better habit is confirming scope, source, and timestamp first, then reading this alongside related notices instead of drawing a conclusion from one record alone.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Baxter Healthcare Corporation initiated a voluntary recall of Clindamycin Injection USP in 5% Dextrose due to CGMP Deviations.
Which Products Are Affected
The recall covers 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, NDC 0338-3814-50. Affected lots are NC185424 (Exp Date: 2/12/2027), NC185479 (Exp Date: 2/13/2027), and NC193948 (Exp Date: 10/23/2027). Distribution includes US Nationwide, Puerto Rico, and Chile.
What You Should Do
Consumers should follow instructions from the recalling firm for returns or further guidance regarding the affected lots.
Why This Matters
The Class II recall addresses potential quality issues from CGMP deviations in a prescription intravenous drug distributed across multiple regions.
Source
FDA recall number D-0815-2026, initiated 2026-08-06.
Original source: FDA Official Notice ↗
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Comparable nationwide notices (length or severity timing) 8
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