Why it was recalled
CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
Product description
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide in the USA and Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0100-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 28, 2017
- FDA report date
- Dec 6, 2017
- Quantity
- 5,355 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- EAI-JR286 INC
Original FDA data
Every field from FDA enforcement report D-0100-2018, exactly as published.
Show all FDA fields
- City
- Torrance
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 78595
- Address
- 20100 S Vermont Ave
- 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
- Postal code
- 90502-1361
- Report date
- Dec 6, 2017
- Product type
- Drugs
- Recall number
- D-0100-2018
- Classification
- Class II
- Recalling firm
- EAI-JR286 INC
- Product quantity
- 5,355 tubes
- Termination date
- Aug 9, 2019
- Reason for recall
- CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Nov 28, 2017
- Initial firm notification
- Center classification date
- Nov 30, 2017