FDA recall D-0813-2018
Milbar Laboratories, Inc. · Class II · drug
Product
Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354.
Reason for recall
GMP Deviations
Distribution
Within the United States and Puerto Rico
Key facts
- Status
- Terminated
- Initiation date
- 2018-05-04
- Report date
- 2018-05-23
- Termination date
- 2019-06-26
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- East Haven, CT, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0813-2018