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Recall Observatory FDA recall evidence

Drug product

Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply

D-0784-2018

April 03, 2018

Class II

Product summary

Firm
Kroger Specialty Pharmacy, Inc.
Event
Event 79748
Status
Terminated
Classification
Class II
Quantity
Unknown
Official record key
drug-enforcement:D-0784-2018

Official wording

Reason: Lack of Processing Controls.

Code information: All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018

Distribution pattern: MS, LA, AR, IL, FL

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls