Drug Enforcement D-0080-2024

Subpotent Drug

Status

Terminated

Classification

Class III

Report Date

November 8, 2023

Termination Date

August 16, 2024

Product Information

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
Product quantity
4548 bottles
Reason for recall
Subpotent Drug
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Edenbridge Pharmaceuticals, LLC
Address
1 Upper Pond Rd, Ste 250

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0080-2024
Event ID
93236
Recall initiation date
October 20, 2023
Center classification date
October 30, 2023
Code info
Lot#: 23ZCP1, Exp. Date 02/22/2026;Lot #:23ZDR1, Exp. Date 03/09/2026
More code info
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