Hydroquinone Cream
FDA Recall NDC 69367-174
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Hydroquinone (NDC 69367-174). A significant event, classified as Class II, was initiated on Sep 23, 2021 by Westminster Pharmaceuticals, Llc. The reported reason for this action was: "Finished product specification did not meet USP specifications."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
September 2021 Class II Recall: Finished product specification did not meet USP specifications.
Recall Number
Class II Terminated
Finished product specification did not meet USP specifications.
Sep 23, 2021
Oct 06, 2021
11,419 tubes
Recall Profile & Regulatory Data
Event ID
88755
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Monarch PCM, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
TN
Termination Date
Jun 23, 2023
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
Batch or Lot Expiration Information
Lot# Lots: 21FP1743, 21FP1745 Exp. 05/2023
Affected Packages Involved in this Recall
69367-174-01Product
Class III Terminated
Subpotency: one product for active ingredient assay and another one for preservative assay
Sep 01, 2021
Sep 29, 2021
6305 tubes
Recall Profile & Regulatory Data
Event ID
88598
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Monarch PCM, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
OH, TN
Termination Date
Jun 21, 2023
Product Description
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
69367-174-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
