FDA recall D-0080-2024

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

Reason for recall

Subpotent Drug

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2023-10-20

Report date

2023-11-08

Termination date

2024-08-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0080-2024