Recalls / Class II
Class IID-0813-2018
Product
Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354.
- Affected lot / code info
- Lot #: KU455-4, Exp.10/30/2020
Why it was recalled
GMP Deviations
Recalling firm
- Firm
- Milbar Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Commerce St, East Haven, Connecticut 06512-4145
Distribution
- Quantity
- 4,815 tubes
- Distribution pattern
- Within the United States and Puerto Rico
Timeline
- Recall initiated
- 2018-05-04
- FDA classified
- 2018-05-15
- Posted by FDA
- 2018-05-23
- Terminated
- 2019-06-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0813-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.