Home / Recalls / Alvogen, Inc / D-0649-2021

D-0649-2021 Class II Terminated

Recalled by Alvogen, Inc — Morristown, NJ

Recall Details

Product Type
Drugs
Report Date
July 14, 2021
Initiation Date
February 26, 2021
Termination Date
February 16, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9,696 cartons

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

Reason for Recall

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

Distribution Pattern

USA nationwide.

Code Information

Lot #: 36924, Exp 6/2021

Other recalls by Alvogen, Inc

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  • D-0245-2025 Class I — Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged (January 31, 2025)
  • D-0353-2023 Class II — Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manuf (February 6, 2023)
  • D-1722-2019 Class II — Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx (July 24, 2019)
  • D-1723-2019 Class II — Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. b (July 24, 2019)
  • D-1277-2019 Class I — FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx on (April 19, 2019)
  • D-0940-2017 Class II — Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE (June 16, 2017)
  • D-0939-2017 Class II — Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE (June 16, 2017)
  • D-0941-2017 Class II — Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE (June 16, 2017)
  • D-0631-2017 Class III — Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufact (March 7, 2017)