Drug product
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
D-0855-2021
Product summary
- Firm
- Monarch PCM, LLC
- Event
- Event 88755
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,419 tubes
- Official record key
drug-enforcement:D-0855-2021
Official wording
Reason: Finished product specification did not meet USP specifications.
Code information: Lots: 21FP1743, 21FP1745 Exp. 05/2023
Distribution pattern: TN
Derived failure modes
-
Unknown
Finished product specification did not meet USP specifications.