Spectra sodium chloride ampules recalled over lack of sterility assurance
0.9% Sodium Chloride Injection, USP in 10 mL single dose ampules supplied for Spectra Medical Devices is being recalled for lack of assurance of sterility. 7,120,750 ampules are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a sterile injectable where sterility cannot be assured, a risk of harm with no injuries reported in the source.
Plain-English summary
0.9% Sodium Chloride Injection, USP, in 10 mL single dose preservative-free ampules, NDC 65282-1510-1, is being recalled. The product is manufactured in Jecheon, Korea for Spectra Medical Devices, LLC of Wilmington, Massachusetts. The action covers 7,120,750 ampules.
The stated reason is lack of assurance of sterility. Sterility is a defining requirement of an injectable product because it is introduced directly into the bloodstream or tissue. The FDA classified the action as Class II.
All lots within expiry are affected. Distribution was USA nationwide.
This is a prescription product supplied to healthcare facilities. Facilities should quarantine affected stock and follow the instructions issued by the manufacturer and distributor.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Huons Co., Ltd.
- Category
- Drug — Injectable solution
- Affected units
- 7,120,750
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Huons Co., Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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