PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: November 8, 2023 Initiated: October 20, 2023 #D-0080-2024

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

Details

Units Affected
4548 bottles
Distribution
Nationwide within the United States
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Edenbridge Pharmaceuticals, LLC. Units affected: 4548 bottles.
Why was this product recalled?
Subpotent Drug
Which agency issued this recall?
This recall was issued by the FDA Drug on November 8, 2023. Severity: Low. Recall number: D-0080-2024.