D-0697-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 11, 2021
- Initiation Date
- June 30, 2021
- Termination Date
- July 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl. oz./119 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-01
Reason for Recall
CGMP Deviations: Does not meet monograph for denaturant.
Distribution Pattern
Distributed to the firm's affiliated facilities and donated third party recipients located in the following states: CT, MA, ME, ND, NY, OR, PA, TX, VT.
Code Information
All distributed lots within expiry