Recalls / Class II
Class IID-0855-2021
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
- Brand name
- Hydroquinone
- Generic name
- Hydroquinone
- Active ingredient
- Hydroquinone
- Route
- Topical
- NDC
- 69367-174
- Affected lot / code info
- Lots: 21FP1743, 21FP1745 Exp. 05/2023
Why it was recalled
Finished product specification did not meet USP specifications.
Recalling firm
- Firm
- Monarch PCM, LLC
- Manufacturer
- Westminster Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7333 Jack Newell Blvd N Ste 100, N/A, Fort Worth, Texas 76118-7151
Distribution
- Quantity
- 11,419 tubes
- Distribution pattern
- TN
Timeline
- Recall initiated
- 2021-09-23
- FDA classified
- 2021-09-27
- Posted by FDA
- 2021-10-06
- Terminated
- 2023-06-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0855-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.