Drug product
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
D-0697-2021
Product summary
- Event
- Event 88222
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0697-2021
Official wording
Reason: CGMP Deviations: Does not meet monograph for denaturant.
Code information: All distributed lots within expiry
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.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations