Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufac
Summary
The FDA issued a Class III for Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 11 by Edenbridge Pharmaceuticals, LLC. Reason: Subpotent Drug.
Details
Source
Drug Recall
External ID
D-0080-2024
Action Date
2023-11-08
Status
Terminated
Category
drug
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
Lot/Code Info: Lot#: 23ZCP1, Exp. Date 02/22/2026;Lot #:23ZDR1, Exp. Date 03/09/2026
Quantity Affected: 4548 bottles
Reason for Recall
Subpotent Drug
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-20
Company
Parsippany, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 33 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Edenbridge Pharmaceuticals, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Edenbridge Pharmaceuticals, LLC have FDA actions?
This is the only FDA action we have on record for Edenbridge Pharmaceuticals, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0080-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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