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Recall Observatory FDA recall evidence

Drug product

Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 mL) UPC 8 70373 01323 1; b) 16 FL OZ (473 mL) UPC 8 70373 01332 3; c) 1 Gallon (128 FL OZ) 3785.41 mL UPC 8 70373 01330 4, Dist. By Target Price, Inc. Catano, PR

D-0260-2023

December 15, 2022

Class II

Product summary

Firm
Frenda Corporation
Event
Event 91325
Status
Terminated
Classification
Class II
Quantity
12,130 bottles
Official record key
drug-enforcement:D-0260-2023

Official wording

Reason: cGMP Deviations

Code information: Lots: a) C012821, C012721, C021821;b) C012521, C021721; c) C021121, C022121

Distribution pattern: Puerto Rico

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations