Home / Recalls / Inopak Ltd / D-0004-2018

D-0004-2018 Class II Terminated

Recalled by Inopak Ltd — Ringwood, NJ

Recall Details

Product Type
Drugs
Report Date
October 11, 2017
Initiation Date
August 23, 2017
Termination Date
April 20, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD, Ringwood, NJ

Reason for Recall

GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.

Distribution Pattern

nationwide

Code Information

All lots within expiry

Other recalls by Inopak Ltd

  • D-1312-2019 Class II — Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel In (April 22, 2019)
  • D-1317-2019 Class II — Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6 (April 22, 2019)
  • D-1316-2019 Class II — Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml D (April 22, 2019)
  • D-1313-2019 Class II — INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCM (April 22, 2019)
  • D-1315-2019 Class II — Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniCl (April 22, 2019)
  • D-1310-2019 Class II — ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foami (April 22, 2019)
  • D-1314-2019 Class II — INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-1 (April 22, 2019)
  • D-1318-2019 Class II — Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap w (April 22, 2019)
  • D-1319-2019 Class II — Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Tric (April 22, 2019)
  • D-1311-2019 Class II — AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chlor (April 22, 2019)