Drug product
Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antiseptic Hand Rub, Non-sterile Solution, Extra strength Formula*, 8.45 fl. oz. (250 ml) bottle, Labeled with green or blue labels, Manufactured by Mystic Intl S.A. de C.V. UPC barcode: 7 87790 33952 6
D-1408-2020
Product summary
- Event
- Event 85957
- Status
- Terminated
- Classification
- Class I
- Quantity
- 20,340 bottles
- Official record key
drug-enforcement:D-1408-2020
Official wording
Reason: Chemical Contamination: Presence of Undeclared Methanol
Code information: Lots: All Lots
Distribution pattern: Distributed Nationwide in the US
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination