Drug product
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01
D-0375-2026
Product summary
- Event
- Event 98291
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0375-2026
Official wording
Reason: CGMP Deviations
Code information: Lot #: 52347-R, 52348-R, 52349-R, 52350, 52351-R, 52352, Exp. Date Mar 2027; 53518, Exp. Date Jun 2027.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations