Multi-event September 2021 FDA Recall Hydroquinone by Monarch Pcm, Llc

This Multi-event Class III drug recall was voluntarily initiated by Monarch Pcm, Llc on September 1, 2021 for the product Hydroquinone. The FDA reported the reason for recall as subpotency. The product was distributed in OH, TN and the recall is currently terminated.

Reported Recall Events

D-0818-2021 TERMINATED D-0817-2021 TERMINATED

Recall Number: D-0818-2021

Reason for Recall
Subpotency: one product for active ingredient assay and another one for preservative assay
Initiated
09-01-2021
Reported
09-29-2021
Quantity
6305 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88598
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
OH, TN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot: 21FP1731 Exp 05/2023

Affected Packages Involved in this Recall

69367-174-01 Hydroquinone

Recall Number: D-0817-2021

Reason for Recall
Subpotency: one product for active ingredient assay and another one for preservative assay
Initiated
09-01-2021
Reported
09-29-2021
Quantity
a) 3305 bottles; b) 840 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88598
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
OH, TN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

Batch or Lot Expiration Information

Lot# Lots: a) 21FP1737 Exp 05/2023; b) 21FP1738 Exp 05/2023