Drug product
Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with Chlorhexidine Gluconate; 1000ML pouches, 8/1000ML pouches per case, Walter G. Legge Co Inc, 444 Central AVE, Peekskill, NY 10566
D-1315-2019
Product summary
- Firm
- Inopak Ltd
- Event
- Event 82645
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,850 pounds per batch
- Official record key
drug-enforcement:D-1315-2019
Official wording
Reason: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Code information: Batch #: 6802, 6803, 6909, 6655
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations