Home / Recalls / Inopak Ltd / D-1313-2019

D-1313-2019 Class II Terminated

Recalled by Inopak Ltd — Ringwood, NJ

Recall Details

Product Type: Drugs
Report Date: June 5, 2019
Initiation Date: April 22, 2019
Termination Date: August 28, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 17,850 pounds per batch

Product Description

INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX, 800ml/27fl.oz.pouches (NDC 058575-110), 12 x 800 Bag-N-Box pouches per case (NDC 058575-110-80), 5014-404-NB; INOPAK, 24 Executive PKWY, Ringwood, NJ 07456.

Reason for Recall

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Distribution Pattern

Nationwide in the USA

Code Information

Batch #: 7074

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-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-1311-2019 Class II — AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chlor (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-0864-2018 Class II — Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, I (May 16, 2018)