Opium Tincture Deodorized Tincture
FDA Recall NDC 42799-217
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 Opium Tincture Deodorized (NDC 42799-217). A significant event, classified as Class III, was initiated on Oct 20, 2023 by Edenbridge Pharmaceuticals, Llc. The reported reason for this action was: "Subpotent Drug"
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
Subpotent Drug
Oct 20, 2023
Nov 08, 2023
4548 bottles
Recall Profile & Regulatory Data
Event ID
93236
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Edenbridge Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Aug 16, 2024
Product Description
Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-01
Batch or Lot Expiration Information
Lot# : 23ZCP1, Exp. Date 02/22/2026
Lot# :23ZDR1, Exp. Date 03/09/2026
Affected Packages Involved in this Recall
42799-217-01Product
42799-217-02Product
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.
