D-0860-2018 Class II Terminated

Recalled by Shadow Holdings DBA Bocchi Labs — Santa Clarita, CA

FDA drug recall D-0860-2018 was initiated by Shadow Holdings DBA Bocchi Labs on May 25, 2018 and is designated Class II. Reason for recall: CGMP Deviations: products may be contaminated with bacteria. The recall status is terminated (terminated August 13, 2019). Affected quantity: 8,208 tubes.

Recall Details

Product Type
Drugs
Report Date
June 20, 2018
Initiation Date
May 25, 2018
Termination Date
August 13, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,208 tubes

Product Description

Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL) tube, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos, CA 90703 USA, UPC 7 80707 73111 6.

Reason for Recall

CGMP Deviations: products may be contaminated with bacteria.

Distribution Pattern

Nationwide in the USA

Code Information

All lots