Home / Recalls / Alvogen, Inc / D-1723-2019

D-1723-2019 Class II Terminated

Recalled by Alvogen, Inc — Pine Brook, NJ

Recall Details

Product Type
Drugs
Report Date
August 21, 2019
Initiation Date
July 24, 2019
Termination Date
August 4, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4272 bottles

Product Description

Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA, NDC 52427-285-01

Reason for Recall

Failed dissolution specifications

Distribution Pattern

Natonwide, PR

Code Information

Lot # 472990, Exp 03/2020

Other recalls by Alvogen, Inc

  • D-0259-2026 Class II — Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Ma (December 31, 2025)
  • 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-0649-2021 Class II — Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing (February 26, 2021)
  • D-1722-2019 Class II — Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx (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-0941-2017 Class II — Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 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-0631-2017 Class III — Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufact (March 7, 2017)