October 2023 FDA Recall Opium Tincture Deodorized by Edenbridge Pharmaceuticals, Llc
D-0080-2024 - Subpotent Drug
This Class III drug recall was voluntarily initiated by Edenbridge Pharmaceuticals, Llc on October 20, 2023 for the product Opium Tincture Deodorized. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0080-2024
Subpotent Drug
10-20-2023
11-08-2023
4548 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Edenbridge Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
08-16-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
