Drug product
Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ (400 mL), Distributed by: Safety-Med Products, Inc. Burlington, WI 53105 Made in Mexico by Asiaticon S.A. de C.V. Conkal No. 62, Mexico, Ciudad de Mexico 14200, Mexico NDC: 75192-600-02 UPC 7 503019 005002
D-0117-2021
Product summary
- Event
- Event 86327
- Status
- Terminated
- Classification
- Class II
- Quantity
- 111,500 units
- Official record key
drug-enforcement:D-0117-2021
Official wording
Reason: Lack of CGMPs:
Code information: All lots.
Distribution pattern: Distributed in Texas
Derived failure modes
-
Manufacturing or process control
Lack of CGMPs