Drug 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
D-0818-2021
Product summary
- Firm
- Monarch PCM, LLC
- Event
- Event 88598
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6305 tubes
- Official record key
drug-enforcement:D-0818-2021
Official wording
Reason: Subpotency: one product for active ingredient assay and another one for preservative assay
Code information: Lot: 21FP1731 Exp 05/2023
Distribution pattern: OH, TN
Derived failure modes
-
Potency or specification failure
Subpotency