Drug product
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.
D-0531-2026
Product summary
- Firm
- Huons Co., Ltd.
- Event
- Event 98724
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7,120,750 ampules
- Official record key
drug-enforcement:D-0531-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: All lots within expiry
Distribution pattern: USA Nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility