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Recall Observatory FDA recall evidence

Drug product

Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00054 7

D-0256-2023

December 15, 2022

Class II

Product summary

Firm
Frenda Corporation
Event
Event 91325
Status
Terminated
Classification
Class II
Quantity
164 bottles
Official record key
drug-enforcement:D-0256-2023

Official wording

Reason: cGMP Deviations

Code information: Lot: C030121

Distribution pattern: Puerto Rico

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations