Why it was recalled
Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity
Product description
eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone. 177.4 ml / 6 fl oz carton containing a tube. Manufactured For: EB5 Corporation Portland, OR 97210 Carton Bar Code: 7 41099 00009 9
Lot numbers, UPCs & expiration codes
Batch B4276A EXP 03/2019
Where it was sold
Distributed Nation Wide in the USA.
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-0908-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 22, 2018
- FDA report date
- Jul 11, 2018
- Quantity
- 4,632 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eb5 Corporation
Original FDA data
Every field from FDA enforcement report D-0908-2018, exactly as published.
Show all FDA fields
- City
- Portland
- State
- OR
- Status
- Terminated
- Country
- United States
- Event ID
- 80359
- Address
- 538 Sw 4th Ave
- Code information
- Batch B4276A EXP 03/2019
- Postal code
- 97204-2102
- Report date
- Jul 11, 2018
- Product type
- Drugs
- Recall number
- D-0908-2018
- Classification
- Class II
- Recalling firm
- Eb5 Corporation
- Product quantity
- 4,632 tubes
- Termination date
- Mar 22, 2023
- Reason for recall
- Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone. 177.4 ml / 6 fl oz carton containing a tube. Manufactured For: EB5 Corporation Portland, OR 97210 Carton Bar Code: 7 41099 00009 9
- Distribution pattern
- Distributed Nation Wide in the USA.
- Recall initiation date
- Jun 22, 2018
- Initial firm notification
- Letter
- Center classification date
- Jul 3, 2018