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Recall Observatory FDA recall evidence

Drug product

+Protec Hands Antibacterial Gel Topical Solution Instant Sanitizer Hands 70% Alcohol Antiseptic, packaged in bottles of a) 33.8 Oz (1000mL) Barcode: GOOD-GEL-04062020L; b) 127.8 oz (3780mL) Barcode 0723707893163, Distributed by: PS Promotional Services LLC Allen Street #406 Dallas, Texas 75204 Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fraccionamiento El Puente. Celaya, Guanajuato, Mexico.

D-0160-2021

November 25, 2020

Class II

Product summary

Firm
Simex Logistics SA de CV
Event
Event 86858
Status
Terminated
Classification
Class II
Quantity
19340 bottles
Official record key
drug-enforcement:D-0160-2021

Official wording

Reason: Subpotent drug

Code information: Lot: 0-820, Exp 07/13/2023

Distribution pattern: CA, GA, NV, TX

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent