FDA Drug Recalls

Recalls / Class II

Class IID-0160-2021

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.

Affected lot / code info
Lot: 0-820, Exp 07/13/2023

Why it was recalled

Subpotent drug

Recalling firm

Firm
Simex Logistics SA de CV
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
Calle Salvatierra Fracc. El Puente 101, Col. Santa Maria, Celaya, Celaya, N/A N/A, Mexico

Distribution

Quantity
19340 bottles
Distribution pattern
CA, GA, NV, TX

Timeline

Recall initiated
2020-11-25
FDA classified
2020-12-16
Posted by FDA
2020-12-23
Terminated
2023-05-17
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0160-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.