Drug product
Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50+, Net. Wt. 2.8 oz (80 g) tube in a carton, Distributed by Vertra/EAI-JR286, 20100 S Vermont Ave, Torrance, CA 90502, Made In Australia, UPC 8 94140 00103 0.
D-0100-2018
Product summary
- Firm
- EAI-JR286 INC
- Event
- Event 78595
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,355 tubes
- Official record key
drug-enforcement:D-0100-2018
Official wording
Reason: CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
Code information: Lot #: 609124, Exp 03/18 Manufacturing batches were mfg at Delta Laboratories under Batch Number 511103 11/16/2015 Batch Number 609124 09/21/2016
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations