FDA recall D-0818-2021

Product

Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217, NDC 69367-174-01 UPC 3 69367 17401 5

Reason for recall

Subpotency: one product for active ingredient assay and another one for preservative assay

Distribution

OH, TN

Key facts

Status

Terminated

Initiation date

2021-09-01

Report date

2021-09-29

Termination date

2023-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fort Worth, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0818-2021