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Terminated

JUDKINS PACK

FDA Recall Z-1256-2021 · Posted None

Recalling FirmCardinal Health 200, LLC
Recall StatusTerminated
Product CodeOEQ
Date Initiated2021-02-11
Date Terminated2022-12-22
Product Quantity298 units

Reason for Recall

Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being reported as intermittently mixed with an incorrect medication label sheet throughout the specific Presource kit SANHDJTVCF Judkins Pack lot # 525067.

Firm Action

The notice "Presource Kits Containing an Incorrect Medication Label Sheet" and reply form dated 02/11/2021 were sent to the customer. For questions, requiring additional labels, or desire special assistance relating to this notice, contact Cardinal Health Quality Systems at 800.292.9332.

Root Cause

Process control

Distribution Pattern

US state of VA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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