Recalls / Class II
Class IID-0812-2018
Product
Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by: BeautyRx LLC, NY, NY 10128
- Affected lot / code info
- Lot #: KU455-2, Exp. 11/09/2020; KU455-6, Exp.11/26/2020
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
- 2,156 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-0812-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.