FDA recall D-0160-2021

Simex Logistics SA de CV · Class II · 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.

Reason for recall

Subpotent drug

Distribution

CA, GA, NV, TX

Key facts

Status
Terminated
Initiation date
2020-11-25
Report date
2020-12-23
Termination date
2023-05-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Celaya, N/A, Mexico

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0160-2021