D-0818-2021 Class III Terminated
FDA drug recall D-0818-2021 was initiated by Monarch PCM, LLC on September 1, 2021 and is designated Class III. Reason for recall: Subpotency: one product for active ingredient assay and another one for preservative assay The recall status is terminated (terminated June 21, 2023). Affected quantity: 6305 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- September 29, 2021
- Initiation Date
- September 1, 2021
- Termination Date
- June 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6305 tubes
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
Reason for Recall
Subpotency: one product for active ingredient assay and another one for preservative assay
Distribution Pattern
OH, TN
Code Information
Lot: 21FP1731 Exp 05/2023