Monarch PCM, LLC: Drug Recall

Recall #D-0855-2021 · 09/23/2021

Class II: Risk

Recall Details

Recall Number
D-0855-2021
Classification
Class II
Product Type
Drug
Recalling Firm
Monarch PCM, LLC
Status
Terminated
Date Initiated
09/23/2021
Location
Fort Worth, TX, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,419 tubes

Reason for Recall

Finished product specification did not meet USP specifications.

Product Description

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

Distribution Pattern

TN

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.