FDA-Drug2021-10-06Class II

Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 NDC 69367-174-01

Monarch PCM, LLC
Hazard

Finished product specification did not meet USP specifications.

Sold states
TN
Affected count
11,419 tubes
Manufactured in
7333 Jack Newell Blvd N Ste 100, N/A, Fort Worth, TX, United States
Products
Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 NDC 69367-174-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0855-2021

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