Drug product
READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use Only, Manufactured by Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-244-01
D-0624-2021
Product summary
- Event
- Event 88005
- Status
- Terminated
- Classification
- Class III
- Quantity
- 231,936 packs
- Official record key
drug-enforcement:D-0624-2021
Official wording
Reason: Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
Code information: Lot #:: 19EEA027, Exp May 2021; 19GEA049, Exp August 2021; 19HEA044, Exp Sept 2021
Distribution pattern: Distributed Nationwide in the USA and Isreal
Derived failure modes
-
Potency or specification failure
Superpotent