Recalls / Class III
Class IIID-0818-2021
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
- Brand name
- Hydroquinone
- Generic name
- Hydroquinone
- Active ingredient
- Hydroquinone
- Route
- Topical
- NDC
- 69367-174
- Affected lot / code info
- Lot: 21FP1731 Exp 05/2023
Why it was recalled
Subpotency: one product for active ingredient assay and another one for preservative assay
Recalling firm
- Firm
- Monarch PCM, LLC
- Manufacturer
- Westminster Pharmaceuticals, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 7333 Jack Newell Blvd N Ste 100, Fort Worth, Texas 76118-7151
Distribution
- Quantity
- 6305 tubes
- Distribution pattern
- OH, TN
Timeline
- Recall initiated
- 2021-09-01
- FDA classified
- 2021-09-20
- Posted by FDA
- 2021-09-29
- Terminated
- 2023-06-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0818-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.