FDA Drug recall D-0818-2021
Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster Pharmaceuticals, LLC Nas…
- FDA Drug
- Class III
- terminated
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class III recall of Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster Pharmaceuticals, LLC Nas… by Monarch Pcm, citing subpotency: one product for active ingredient assay and another one for preservative assay.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0818-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-09-01 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Monarch Pcm |
| Distribution | OH, TN |
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
Reason
Subpotency: one product for active ingredient assay and another one for preservative assay
Identifiers
| upc | 369367174015 |
|---|---|
| ndc | 69367-174-01 |
| code_info | Lot: 21FP1731 Exp 05/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0818-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.