D-0812-2018 Class II Terminated
FDA drug recall D-0812-2018 was initiated by Milbar Laboratories, Inc. on May 4, 2018 and is designated Class II. Reason for recall: GMP Deviations The recall status is terminated (terminated June 26, 2019). Affected quantity: 2,156 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- May 23, 2018
- Initiation Date
- May 4, 2018
- Termination Date
- June 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,156 tubes
Product Description
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
Reason for Recall
GMP Deviations
Distribution Pattern
Within the United States and Puerto Rico
Code Information
Lot #: KU455-2, Exp. 11/09/2020; KU455-6, Exp.11/26/2020