September 2021 FDA Recall Hydroquinone by Monarch Pcm, Llc
D-0855-2021 - Finished product specification did not meet USP specifications.
This Class II drug recall was voluntarily initiated by Monarch Pcm, Llc on September 23, 2021 for the product Hydroquinone. The FDA reported the reason for recall as finished product specification did not meet usp specifications.. The product was distributed in TN and the recall is currently terminated.
Recall Number: D-0855-2021
Finished product specification did not meet USP specifications.
09-23-2021
10-06-2021
11,419 tubes
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Monarch PCM, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
TN
06-23-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# Lots: 21FP1743, 21FP1745 Exp. 05/2023
