Home / Recalls / Aidarex Pharmaceuticals LLC / D-0974-2016

D-0974-2016 Class III Terminated

Recalled by Aidarex Pharmaceuticals LLC — Corona, CA

Recall Details

Product Type
Drugs
Report Date
June 15, 2016
Initiation Date
June 1, 2016
Termination Date
October 14, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10

Product Description

CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01

Reason for Recall

CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.

Distribution Pattern

IN, GA

Code Information

Lot#: 47312-1, Exp 01/2018

Other recalls by Aidarex Pharmaceuticals LLC

  • D-0991-2018 Class III — Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharm (June 27, 2018)
  • D-0990-2018 Class III — Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pha (June 27, 2018)
  • D-0992-2018 Class III — Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharm (June 27, 2018)
  • D-0810-2018 Class III — Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00 (April 10, 2018)
  • D-0053-2018 Class III — ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt L (September 5, 2017)
  • D-1162-2017 Class III — Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidare (September 5, 2017)
  • D-0975-2016 Class II — CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG (June 1, 2016)
  • D-1061-2016 Class III — Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Rep (June 1, 2016)
  • D-0042-2015 Class II — Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Phar (May 22, 2014)