Home / Recalls / Inopak Ltd / D-0864-2018

D-0864-2018 Class II Terminated

Recalled by Inopak Ltd — Ringwood, NJ

Recall Details

Product Type
Drugs
Report Date
June 20, 2018
Initiation Date
May 16, 2018
Termination Date
October 23, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1345 cases

Product Description

Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ

Reason for Recall

Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts

Distribution Pattern

Nationwide

Code Information

7302 01 039, 7302 03 039, 7302 01 040 and 7302 01 043

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)