D-0065-2019 Class II Terminated
FDA drug recall D-0065-2019 was initiated by Product Quest Manufacturing LLC on Aug 3, 2018 and is designated Class II. Reason for recall: Failed Stability Specifications: separation of product and failure for actives. The recall status is terminated (terminated Mar 30, 2021). Affected quantity: 9,480 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 24, 2018
- Initiation Date
- Aug 3, 2018
- Termination Date
- Mar 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,480 tubes
Product Description
dr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube, Distributed by: Cosmetic Dermatology, Inc., Miami, FL 33172, UPC 6 63963 00828 7.
Reason for Recall
Failed Stability Specifications: separation of product and failure for actives.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 161223D, Exp. 4/16/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0065-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026