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Custopharm, Inc. Recall: FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single

Custopharm, Inc. Recall: FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Custopharm, Inc.; Product: FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Ca

Recalling firmCustopharm, Inc.
ProductFLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01
Reason for recallLack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionDistributed Nationwide in the USA
Recall initiated20210730
Recall numberD-0765-2021
Categorydrug
StateCA
CountryUnited States

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