D-0071-2019 Class II Terminated
FDA drug recall D-0071-2019 was initiated by Product Quest Manufacturing LLC on Aug 3, 2018 and is designated Class II. Reason for recall: Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus. The recall status is terminated (terminated Mar 30, 2021). Affected quantity: 25,596 sticks.
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
- 25,596 sticks
Product Description
CeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%, octisalate 5%, octocrylene 10%, Net Wt. 0.15 oz. (4.25 g) stick, CeraVe LLC., New York, NY 10001, UPC 3 01872 49201 7.
Reason for Recall
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: PSP85W/172792H
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0071-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026