D-0080-2024 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 8, 2023
- Initiation Date
- October 20, 2023
- Termination Date
- August 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4548 bottles
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
Reason for Recall
Subpotent Drug
Distribution Pattern
Nationwide within the United States
Code Information
Lot#: 23ZCP1, Exp. Date 02/22/2026;Lot #:23ZDR1, Exp. Date 03/09/2026