D-0590-2018 Class II Terminated
FDA drug recall D-0590-2018 was initiated by Bayer HealthCare Pharmaceuticals, Inc. on Feb 23, 2018 and is designated Class II. Reason for recall: Labeling: Label mix-up The recall status is terminated (terminated Jan 9, 2020). Affected quantity: 528 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 14, 2018
- Initiation Date
- Feb 23, 2018
- Termination Date
- Jan 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 528 units
Product Description
Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bayer Healthcare LLC Whippany, NJ 07981, UPC 41100573636.
Reason for Recall
Labeling: Label mix-up
Distribution Pattern
Arkansas only
Code Information
Lot#: 7N04CS, 7N05CS, Exp. 11/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0590-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026