D-0004-2018 Class II Terminated
FDA drug recall D-0004-2018 was initiated by Inopak Ltd on Aug 23, 2017 and is designated Class II. Reason for recall: GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump. The recall status is terminated (terminated Apr 20, 2020).
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 11, 2017
- Initiation Date
- Aug 23, 2017
- Termination Date
- Apr 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0004-2018
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026