Home / Recalls / Alvogen, Inc / D-0630-2017

D-0630-2017 Class III Terminated

Recalled by Alvogen, Inc — Pine Brook, NJ

Recall Details

Product Type
Drugs
Report Date
April 12, 2017
Initiation Date
March 7, 2017
Termination Date
December 15, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01.

Reason for Recall

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Distribution Pattern

Nationwide

Code Information

Lot #: BXH1P41, BXH1BEE1, BXH1BE2, BXH1BE1B, BXH1BE1A, BXH1P41A, Exp. 01/2018; BXH81R1, BXHBD41A, BXH5ZR1, BXH9AL1A, Exp. 06/2018; BXHCUD1A, BXHCUF2A, Exp. 01/2019.

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  • 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-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-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)