Why it was recalled
Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into the Obagi Exfoderm Forte packaging line. Therefore customers which ordered Clear RX actually had contents of Exfoderm forte.
Product description
Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching and Corrector Cream, Hydroquinone USP, 4%, Rx Only, Net Wt. 2 OZ. (57 g) bottle, Dist by OMP Inc, Long Beach CA 90802, Made in USA, NDC 62032-101-36
Lot numbers, UPCs & expiration codes
Lot #: 13I1218, Product/Part #: 362032101361, Exp 09/30/2016
Where it was sold
Nationwide and Mexico and Slovenia
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-0234-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 17, 2014
- FDA report date
- Nov 12, 2014
- Quantity
- 975 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Obagi Medical Products
Original FDA data
Every field from FDA enforcement report D-0234-2015, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 69569
- Address
- 50 Technology Dr
- Code information
- Lot #: 13I1218, Product/Part #: 362032101361, Exp 09/30/2016
- Postal code
- 92618-2301
- Report date
- Nov 12, 2014
- Product type
- Drugs
- Recall number
- D-0234-2015
- Classification
- Class II
- Recalling firm
- Obagi Medical Products
- Product quantity
- 975 bottles
- Termination date
- Apr 29, 2015
- Reason for recall
- Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into the Obagi Exfoderm Forte packaging line. Therefore customers which ordered Clear RX actually had contents of Exfoderm forte.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching and Corrector Cream, Hydroquinone USP, 4%, Rx Only, Net Wt. 2 OZ. (57 g) bottle, Dist by OMP Inc, Long Beach CA 90802, Made in USA, NDC 62032-101-36
- Distribution pattern
- Nationwide and Mexico and Slovenia
- Recall initiation date
- Oct 17, 2014
- Initial firm notification
- Letter
- Center classification date
- Oct 31, 2014