Alvogen, Inc: Drug Recall

Recall #D-0649-2021 · 02/26/2021

Class II: Risk

Recall Details

Recall Number: D-0649-2021
Classification: Class II
Product Type: Drug
Recalling Firm: Alvogen, Inc
Status: Terminated
Date Initiated: 02/26/2021
Location: Morristown, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9,696 cartons

Reason for Recall

Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)

Product Description

Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03

Distribution Pattern

USA nationwide.

Other Recalls by Alvogen, Inc

Class II: Risk 12/31/2025

Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Class I: Dangerous 01/31/2025

Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Class II: Risk 02/06/2023

Sub-Potent Drug: Out of specification for assay at the 24 month interval.

View all recalls by Alvogen, Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.