Drug product
Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01.
D-0659-2026
Product summary
- Event
- Event 99204
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0659-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: AE3102, 031926L01, 032026A01, Exp 11/30/2026; AE5052, 052026G01, Exp 04/30/2028.
Distribution pattern: USA Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility