Class II · Moderate risk
Imipenem/Cilastatin 2000mg in Ns 400ml
Lack of sterility assurance
Most common reason: Sterility / contamination (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cilastatin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Lack of sterility assurance
Lack of Assurance of Sterility
Lack of sterility assurance.
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