Recall Register

Drug recall: Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, Inc., Long Beach, CA…

Class III FDA enforcement event 77659. Recall start date: . Status in the FDA record: Terminated. Termination date: .

Reason for recall, in the words of FDA

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.

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Valeant Pharmaceuticals North America LLC started this drug recall on 28 Jun 2017. The firm address in the FDA record is in Bridgewater, NJ. FDA put the recall in Class III. FDA event 77659 has 1 product record. The first FDA enforcement report date is 26 Jul 2017. The record gives the status Terminated, with the termination date 16 Jan 2018.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Distribution

In the words of FDA.

U.S. Nationwide

Recalling firm

Valeant Pharmaceuticals North America LLC, Bridgewater, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 77659: product records
Recall numberProductQuantityClassStatusReport date
D-0998-2017Obagi-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 62032-222-02844 bottlesClass IIITerminated26 Jul 2017

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class III: The lowest of the three FDA recall classes.

The event in context

Drug events that started in 2017
343
Share of these events in Class III
30%
Product records in this event
1Median of the firm: 1
Events of the firm on the register
14

Other events of the firm

Other FDA enforcement events of Valeant Pharmaceuticals North America LLC
InitiatedProduct (first record)TypeClassRecords
30 Jan 2019Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottleDrugClass III5
24 Aug 2018Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant DrugClass II3
10 Jul 2018Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricatingDrugClass III1
20 Mar 2017CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America DrugClass III2
10 Jun 2016SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant PharmaceutDrugClass III1
23 May 2016Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: ValeaDrugClass III1
14 Sep 2015Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic DeviceClass II1
4 Sep 2015Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 921DrugClass II1
18 Apr 2015Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in CanDrugClass III2
17 Apr 2015Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USADrugClass II1

Valeant Pharmaceuticals North America LLC: all 14 events

Official channels

Cite this page

Recall Register. FDA enforcement event 77659. https://recallregister.com/fda/iii/77659/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA drug enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
Newest FDA report date on the register
23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?
The FDA record gives this distribution: U.S. Nationwide
What quantity of product is in FDA event 77659?
The FDA record gives this quantity: 844 bottles
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2017 have the same class?
30% of the 343 drug events that started in 2017 are in Class III.