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Recall Observatory FDA recall evidence

Drug product

Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01 Distributed By: Cypress Pharmaceutical, Inc. 135 Industrial Blvd. Madison, MS 39110

D-0467-2021

March 15, 2021

Class II

Product summary

Firm
Cardinal Health Inc.
Event
Event 87512
Status
Terminated
Classification
Class II
Quantity
1 bottle
Official record key
drug-enforcement:D-0467-2021

Official wording

Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Code information: All Lots distributed 02/23/2021 through 03/10/2021.

Distribution pattern: FL, GA, SC

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations