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X-Gen Pharmaceuticals Inc. FDA Recalls

3 recalls on file across drugs, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, AClass IIIApr 2, 2024Labeling: Incorrect or missing Package Insert: There is an e
Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Class IIIApr 2, 2024Labeling: Incorrect or missing Package Insert: There is an e
Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc.Class IIMar 19, 2021Failed Stability Specifications: Out of Specification (OOS)

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