Home / Recalls / Aidarex Pharmaceuticals LLC / D-0990-2018

D-0990-2018 Class III Terminated

Recalled by Aidarex Pharmaceuticals LLC — Corona, CA

Recall Details

Product Type
Drugs
Report Date
August 1, 2018
Initiation Date
June 27, 2018
Termination Date
December 4, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11, 90-count bottles

Product Description

Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90

Reason for Recall

Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

Distribution Pattern

Distributed Nationwide in the USA

Code Information

Lots: 56698-1, EXP 1/31/2019; 56698-2, EXP 4/30/2019

Other recalls by Aidarex Pharmaceuticals LLC

  • D-0992-2018 Class III — Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharm (June 27, 2018)
  • D-0991-2018 Class III — Enalapril Maleate, USP 5MG, 90-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-1162-2017 Class III — Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidare (September 5, 2017)
  • D-0053-2018 Class III — ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt L (September 5, 2017)
  • D-0974-2016 Class III — CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Pa (June 1, 2016)
  • 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)