D-0004-2018 Class II Terminated
FDA drug recall D-0004-2018 was initiated by Inopak Ltd on August 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 April 20, 2020). Affected quantity: N/A.
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