Drug product
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.
D-0554-2026
Product summary
- Event
- Event 98976
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 210625 ampules
- Official record key
drug-enforcement:D-0554-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.
Distribution pattern: USA Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility