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Recall Observatory FDA recall evidence

Drug product

Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92

D-0091-2019

August 10, 2018

Class II

Product summary

Firm
Westlab Pharmacy, Inc. dba Westlab Pharmacy
Event
Event 80838
Status
Terminated
Classification
Class II
Quantity
7 droptainers
Official record key
drug-enforcement:D-0091-2019

Official wording

Reason: Lack of Process Controls

Code information: Lot: 07262018@7 Exp. 08/25/2018

Distribution pattern: Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Process Controls