D-0855-2021 Class II Terminated
FDA drug recall D-0855-2021 was initiated by Monarch PCM, LLC on September 23, 2021 and is designated Class II. Reason for recall: Finished product specification did not meet USP specifications. The recall status is terminated (terminated June 23, 2023). Affected quantity: 11,419 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- October 6, 2021
- Initiation Date
- September 23, 2021
- Termination Date
- June 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,419 tubes
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
Reason for Recall
Finished product specification did not meet USP specifications.
Distribution Pattern
TN
Code Information
Lots: 21FP1743, 21FP1745 Exp. 05/2023