Why it was recalled
Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information.
Product description
Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, Inc., Long Beach, CA Made in USA, NDC 62032-222-02
Lot numbers, UPCs & expiration codes
Lot #: 2578400, 0Exp 8/2019
Where it was sold
U.S. Nationwide
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-0998-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 28, 2017
- FDA report date
- Jul 26, 2017
- Quantity
- 844 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Valeant Pharmaceuticals North America LLC
Original FDA data
Every field from FDA enforcement report D-0998-2017, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77659
- Address
- 400 Somerset Corporate Blvd
- Code information
- Lot #: 2578400, 0Exp 8/2019
- Postal code
- 08807-2867
- Report date
- Jul 26, 2017
- Product type
- Drugs
- Recall number
- D-0998-2017
- Classification
- Class III
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- Product quantity
- 844 bottles
- Termination date
- Jan 16, 2018
- Reason for recall
- Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, Inc., Long Beach, CA Made in USA, NDC 62032-222-02
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Jun 28, 2017
- Initial firm notification
- Letter
- Center classification date
- Jul 14, 2017