Diazepam Gel
FDA Recall NDC 68682-652
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Diazepam (NDC 68682-652). A significant event, classified as Class III, was initiated on Jul 10, 2018 by Oceanside Pharmaceuticals. The reported reason for this action was: "Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Jul 10, 2018
Aug 15, 2018
306 cartons
Recall Profile & Regulatory Data
Event ID
80662
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Valeant Pharmaceuticals North America LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Feb 05, 2019
Product Description
Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instructions for use per carton, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807; Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215; NDC 68682-650-20.
Batch or Lot Expiration Information
Lot# : NBBN, Exp 02/22
Affected Packages Involved in this Recall
68682-652-20Product
68682-655-20Product
68682-650-20Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
